FDA: Ameridose Announces Voluntary Recall Of All Products

Photo Credit CDC

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Ameridose, a sister company to the New England Compounding Center (NECC) – the pharmacy at the center of investigation involving contaminated steroid products – has announced a voluntary recall of all of their products as their facilities are coming under review by the FDA.

 

The FDA reassures that - This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution.

 

The company posted a carefully worded announcement on their website earlier today:

 

Ameridose Issues Recall of All Products

Contact:
Consumer:
888-820-0622
amdservice@ameridose.com

FOR IMMEDIATE RELEASE - October 31, 2012 - Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S.Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.

 

During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.  Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death.

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The first sentence in the second paragraph of their press release, which reads . . .

 

During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.

 

. . .  is apparently their interpretation of the FDA’s assessment from below, which states:

 

FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.

 

Without comment, I'll also mention that both parties managed to agree that injecting non-sterile products is generally a bad idea, and represents a - `serious hazard to health and could lead to life-threatening injuries and/or death’.

 

Moving on.   Here is the FDA’s statement in its entirety.

 

 

    FDA NEWS RELEASE

For Immediate Release: Oct. 31, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reports voluntary recall of all Ameridose drug products

The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo . A complete list of all products subject to this recall can be accessed at www.ameridose.com .

 
The FDA is currently conducting an inspection of Ameridose’s facility. Although this inspection is ongoing, the FDA’s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on Oct. 10, 2012.

 

This recall is not based on reports of patients with infections associated with any of Ameridose’s products, and the agency recommended this recall out of an abundance of caution. Therefore, at this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

 

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.

 

“The FDA’s top priority is to ensure that drugs are safe for the American public,” said FDA Commissioner Margaret A. Hamburg, M.D.

 

Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.

 

“Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,” explained Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

 

The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs.

 

“The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies,” added Commissioner Hamburg.

 

As new information becomes available, the FDA will issue additional public communications.

 

Health care professionals and patients may dial the FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

 

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

CDC Updates On Fungal Meningitis Outbreak

Credit CDC

 

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The outbreak of a rare form of fungal meningitis – linked to contaminated injectable steroids prepared by a New England pharmacy & shipped to clinics in 27 states - continues to expand this weekend, with 91 cases and 7 fatalities now confirmed.

 

 

While serious, this form of meningitis is not transmissible between people. If you did not receive an epidural injection with this recalled steroid, you are not at risk.

 

While strongly suspected, the link to this steroid is not yet conclusively proven. Hence the use of terms on the CDC site like `potentially contaminated’.  NECC, the compounding pharmacy, has voluntarily recalled all of their products.

 

 

The fungi found in patients thus far are aspergillus and exserohilum – both of which are commonly found in the environment.

 

While we all are exposed to these fungal spores in our daily lives, it is believed that by injecting them directly into the spine, it enabled them to easily penetrate the membranes covering the brain and spinal cord (the meninges).

 

 

Yesterday’s CDC update indicates that `potentially contaminated injections were given starting May 21, 2012’, which is much earlier than previously expected.  Here is the CDC’s summary of the situation, followed by last night’s update:

Summary:

CDC is coordinating a multistate investigation of meningitis among patients who received epidural steroid injections (medication injected into the spine). Several of these patients have had strokes related to the meningitis. In several patients, the meningitis was found to be caused by a fungus that is common in the environment but rarely causes meningitis. This form of meningitis is not contagious. The source of the fungus has not yet been identified, and the cause of infections in the other patients is still being assessed.

Multistate Meningitis Outbreak Investigation

October 7, 2012 7:30 PM EDT

• CDC is aware that New England Compounding Center has voluntarily expanded its recall to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.
• CDC's guidance to patients has not changed as a result of this voluntary recall. Patients who feel ill and are concerned about whether they received a medication from NECC should contact their physicians.
• Clinicians should actively contact patients who have received medicines associated with three lots of preservative-free methylprednisolone acetate (80mg/ml) recalled on September 26. The potentially contaminated injections were given starting May 21, 2012. Symptoms that should prompt diagnostic evaluation include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site.

The CDC has also updated a FAQ for patients. I’ve only excerpted a portion below, so follow the link to read it in its entirety.

Frequently Asked Questions For Patients: Multistate Meningitis Outbreak Investigation

October 7, 2012 7:00 PM EDT

(EXCERPT)

What should patients do?

Find out if you received a potentially contaminated medication. If patients are concerned about which product was used in their procedure, they should first contact the physician who performed their procedure.

 

The facilities who received one of the lots recalled on September 26, 2012, are actively contacting patients to find out if they are feeling well. The list of facilities that received medication from one of these three lots is available at http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html.

 

If you have received a potentially contaminated medication, seek medical attention if you have symptoms. It is important to note that infected patients have had very mild symptoms that are only slightly worse than usual. For example, many infected patients have had slight weakness, slightly worsened back pain, or even a mild headache. Patients have had symptoms generally starting from 1 to 4 weeks after their injection.

 

Patients who have had an epidural steroid injection since May 21, 2012, and have any of the following symptoms, should talk to their doctor as soon as possible:

• New or worsening headache
• Fever
• Sensitivity to light
• Stiff neck
• New weakness or numbness in any part of your body
• Slurred speech
• Increased pain, redness or swelling at your injection site

 

This incident has thrust the little-regulated world of compounding pharmacies into the limelight, and as the following article from the WSJ indicates, the FDA would like to have greater oversight – particularly on those pharmacies that ship large quantities of drugs across the country.

 

Meningitis Cases Rise Amid Hunt for Victims

Updated October 7, 2012, 8:31 p.m. ET

By TIMOTHY W. MARTIN, THOMAS M. BURTON, BETSY MCKAYand JENNIFER LEVITZ

 

 

And finally, late last week the CDC issued a HAN Advisory to clinicians around the country advising them of these potentially contaminated steroids, and the risks of meningitis and strokes linked to them. 

 

You can read it by clicking the image below:

 

 

As the suspected drugs were in use until late September, and this type of meningitis can take a month or more to develop symptoms, the CDC believes that cases could continue to rise over the next few weeks. 

Salmonella-Related Egg Recall Expands

 

 

 

# 4834

 

 

The shell egg recall over possible Salmonella-related contamination continues to grow, with a 23rd state (Michigan) now involved.  Lisa Schnirring writing for CIDRAP News has the latest, after which I’ll return with some FDA and CDC resources.

 

 

States affected by egg recall grow to 23

Lisa Schnirring Staff Writer

Aug 25, 2010 (CIDRAP News) – Agriculture officials in Michigan said yesterday that eggs connected to the national Salmonella-related recall have been distributed in the state, though it wasn't mentioned in recall notices by the two Iowa companies at the center of the investigation, Wright County Egg and Hillandale Farms.

 

The Michigan Department of Agriculture said in a statement that an ongoing traceback investigation has revealed that some of the companies' customers are distributors and wholesalers that sold the eggs to Michigan customers.

 

Michigan's announcement raises the number of states affected by the recall to 23, according to a review of company recall notices. The two companies have recalled about 500 million eggs. Four smaller companies that repackaged and resold the eggs from the two companies have also issued recalls.

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The FDA maintains a webpage on this recall, and continually adds new resources and links.

 

Recall of Shell Eggs

Updated August 26, 2010

Topics on this page:

• Introduction
• Identifying Recalled Brands and Products
• News Updates
• Consumer Health Information
• Information about Egg Safety and Salmonella
• Investigation into the Salmonella and Shell Egg Outbreak

---

Introduction

An outbreak of Salmonella Enteritidis (SE) that has sickened hundreds of people across the country has led to a recall of shell eggs. On August 13, Wright County Egg voluntarily conducted a nationwide recall of shell eggs on 3 of its 5 farms. Further epidemiologic and traceback information led to Wright County Egg expanding its recall on August 18 to cover all 5 farms and 380 million eggs (according to company figures). The FDA is monitoring the recall, including conducting audit checks at retail stores, wholesalers, and distributors to make sure the recalled shell eggs are being removed from the market. The FDA is in ongoing communications with Wright County Egg to ensure that appropriate preventive measures are put in place to reduce the risk of recurrence.

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The CDC meanwhile offers some advice on how to limit your chances of contracting Salmonella  Enteritidis from shell eggs on their Tips to Reduce Your Risk of Salmonella from Eggs webpage.

 

What are the specific actions I can take to reduce my risk of a Salmonella Enteritidis infection?

1. Keep eggs refrigerated at ≤ 45° F (≤7° C) at all times.
2. Discard cracked or dirty eggs.
3. Wash hands, cooking utensils, and food preparation surfaces with soap and water after contact with raw eggs.
4. Eggs should be cooked until both the white and the yolk are firm and eaten promptly after cooking.
5. Do not keep eggs warm or at room temperature for more than 2 hours.
6. Refrigerate unused or leftover egg-containing foods promptly.
7. Avoid eating raw eggs.
8. Avoid restaurant dishes made with raw or undercooked, unpasteurized eggs. Restaurants should use pasteurized eggs in any recipe (such as Hollandaise sauce or Caesar salad dressing) that calls for raw eggs.
9. Consumption of raw or undercooked eggs should be avoided, especially by young children, elderly persons, and persons with weakened immune systems or debilitating illness.

Who is most at risk for getting Salmonella Enteritidis?

The elderly, infants, and those with impaired immune systems may have a more severe illness. In these patients, the infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.

How do I know if I have Salmonella Enteritidis?

A person infected with the Salmonella Enteritidis bacterium usually has fever, abdominal cramps, and diarrhea beginning 12 to 72 hours after consuming a contaminated food or beverage. The illness usually lasts 4 to 7 days, and most persons recover without antibiotic treatment. However, the diarrhea can be severe, and the person may be ill enough to require hospitalization.

Australia: CSL Recalls Pediatric Flu Vax

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About six weeks ago we began seeing reports of an unexpected number of adverse side effects among children under the age of 5 who had received CSL Ltd. Fluvax seasonal flu vaccine. 

 

The total number or reports were small (several hundred) out of thousands of shots given, but significantly higher than normal.

 

Most of the side effects were related to fever, with some children experiencing febrile convulsions. Others experienced nausea and vomiting, or injection site inflammation (see Australia Investigating Adverse Vaccine Reactions).  

 

Within days, doctors were advised to suspend giving the shots pending an investigation. No causative agent has been identified, but the company has decided to `retrieve’ all unused doses of the vaccine.

 

CSL’s Fluvax is the first seasonal vaccine to contain the novel (pandemic) H1N1 antigen along with the new H3N2 antigen and a `B’ influenza component.  

 

The monovalent (single antigen) panvax shot for novel H1N1 did not produce these sorts of reactions, and is being recommended for children in Australia instead.

 

Flu vaccines have historically been very safe, and so why this particular formulation should have produced this level of febrile reactions in young children is a bit of a mystery. 

 

One that scientists, no doubt, will continue to be looking at over the summer.

 

This from Bloomberg Businessweek.  A hat tip to RoRo on FluTrackers for this link.

 

CSL Recalls Flu Shot as Side Effects Rise Nine-Fold (Update1)

June 01, 2010, 6:22 AM EDT

 

By Simeon Bennett

June 1 (Bloomberg) -- CSL Ltd., the Southern Hemisphere’s only flu vaccine maker, recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions.

CSL is voluntarily withdrawing unused doses of its Fluvax Junior shot from clinics and distributors, the Melbourne-based company said in a statement today. Jim Bishop, Australia’s chief medical officer, said vaccinations should continue to be suspended for children under 5 years, a recommendation initially made on April 23.

 

Fluvax was linked to febrile convulsions in about 9 children in every 1,000 who got the shot, higher than the expected rate of 1 per 1,000, Bishop said in a separate statement. It’s unclear whether Sanofi-Aventis SA’s Vaxigrip and Solvay SA’s Influvac caused similar side effects because insufficient doses have been used in Australia, he said.

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Hold The Lettuce

 

 

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E. coli is a bacterium that commonly found in the lower intestines of warm blooded organisms, and while many strains are harmless, a few are capable of causing serious illness in humans.

 

Pathogenic strains of  E. coli can cause such diverse disease processes as gastroenteritis, urinary tract infections, septicemia and on rare occasions hemolytic-uremic syndrome (HUS), which can damage kidney function and has about a 10% mortality rate.

 

Over the years we’ve seen a number of food recalls due to suspected (or confirmed) E. coli contamination, most often associated with meat, but sometimes involving produce and processed foods, and even raw cookie dough.

 

From Foodsafety.gov we get this description of E. coli.

 

E. coli is the name of a type of bacteria that lives in your intestines. Although most types of E. coli are harmless, some types can make you sick. The worst type of E. coli, known as E. coli O157:H7, causes bloody diarrhea and can sometimes cause kidney failure and even death.

Sources

Undercooked beef especially hamburger, unpasteurized milk and juice, raw fruits and vegetables (such as sprouts), soft cheeses made from raw milk, feces of infected people, and contaminated water.

Incubation Period

1-8 days

Symptoms

Severe diarrhea that is often bloody, abdominal pain and vomiting. Usually, little or no fever is present.

Duration of Illness

5-10 days

What Do I Do?
Drink plenty of fluids and get rest. If you cannot drink enough fluids to prevent dehydration or if your symptoms are severe, call your doctor. Antibiotics should not be used to treat this infection.

 

Today we’ve news of another multi-state recall, this time of lettuce that may be contaminated with E. coli.    This from the CDC:

 

Investigation Announcement: Multistate Outbreak of Human E. coli O145 Infections Linked to Shredded Romaine Lettuce from a Single Processing Facility

Updated May 6, 2010

Confirmed cases of E. coli O145 Infection, United States, by state

Click to view a larger image.

Infections with the outbreak strain of E. coli O145, by date of illness onset (n=19 for whom information was reported as of January 4, 2010)

Click to view a larger image.

Local and state public health officials in Michigan, New York, and Ohio are investigating human illnesses caused by E. coli O145. CDC is supporting these investigations and facilitating regular communication and information sharing between the states and with the U.S. Food and Drug Administration (FDA).

 

As of May 5, 2010, a total of 19 confirmed and 10 probable cases related to this outbreak have been reported from 3 states since March 1, 2010. The number of ill persons identified in each state with this strain is strain is: MI (10 confirmed and 3 probable), NY (2 confirmed and 5 probable), and OH (7 confirmed and 2 probable).

 

Among the confirmed and probable cases with reported dates available, illnesses began between April 10, 2010 and April 26, 2010. Infected individuals range in age from 13 years old to 29 years old and the median age is 19 years. Sixty-nine percent of patients are male. Among the 29 patients with available information, 12 (41%) were hospitalized. Three patients have developed a type of kidney failure known as hemolytic-uremic syndrome, or HUS. No deaths have been reported.

 

The outbreak can be visually described with a chart showing the number of persons who became ill each day. This chart is called an epidemic curve or epi curve. Of note, it takes an average of 2 to 3 weeks from the time a person becomes ill to the time when the illness is confirmed by laboratory testing and reported. Please see the E. coli Outbreak Investigations: Timeline for Reporting Cases for more details.

 

The bacteria responsible for this outbreak are referred to as Shiga toxin-producing E. coli, or STEC. STECs have been associated with human illness, including bloody diarrhea and a potentially fatal kidney condition called hemolytic-uremic syndrome (HUS). STEC bacteria are grouped by serotypes (e.g., O157 or O145). The STEC serotype found most commonly in U.S. patients is E. coli O157. Other E. coli serotypes in the STEC group, including O145, are sometimes called “non-O157 STECs.” Currently, there are limited public health surveillance data on the occurrence of non-O157 STECs, including E. coli O145, therefore E.coli O145 may go unreported. Because it is more difficult to identify than E. coli O157, many clinical laboratories do not test for non-O157 STEC infection.

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You’ll find an FDA announcement on this recall at:

FDA Supports Freshway Foods Voluntary Recall of Lettuce

And more information on E. coli at the CDC’s  E. coli information page:

Non-Safety Related Vaccine Recall

 

 

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Although some headlines are screaming `5 million doses of flu vaccine being recalled’, the reality is a bit less dramatic than these banners might suggest. 

 

Maryland based MedImmune, makers of FluMist, has voluntarily recalled the remaining doses from 13 lots of vaccine sent out in October and November.  While the original lots consisted of 4.7 million doses . . . the `vast majority’ of those  have already been dispensed.

 

Once again, the concern is a reduction in potency over time, not over any safety concerns.

 

Vaccine manufacturers retain a small portion of each lot of vaccine produced and perform ongoing potency tests.  In this case, the potency of the FluMist dropped over time.

 

 

The FDA states that those who took the nasal spray vaccine received a sufficient dose of antigen to afford protection, and need not get another dose.

 

This is the second time this month that H1N1 vaccines  have been withdrawn due to a drop in antigenic potency over time.  Just over a week ago I reported on Sanofi: Non-Safety Related Recall Of 800K Doses Of Vaccine.

 

Tom Randall of Bloomberg News has more details.

 

AstraZeneca’s Swine Flu Nasal Spray Recalled for Lower Potency

December 23, 2009, 02:53 AM EST

Dec. 23 (Bloomberg) -- AstraZeneca Plc recalled 4.7 million doses of its nasal spray version of the swine flu vaccine after routine tests showed a decline in potency, U.S. regulators said.

 

The doses remain safe, and people who have already been inoculated don’t need to get vaccinated again, said Norman Baylor, director of vaccines research and review for the U.S. Food and Drug Administration. About 3,000 of the affected doses remain in warehouses, and AstraZeneca will send recall notices to clinics that may have unused vials of the vaccine.

 

The recall follows a similar move on Dec. 15 by Paris-based Sanofi-Aventis SA, which recalled 800,000 swine flu shots. Manufacturers maintain samples for testing from each vaccine lot that is shipped, and they continue to test them for waning potency, Baylor said. Both recalls were made voluntarily after the strength dropped below pre-specified thresholds.

 

“There are no safety concerns with these lots,” Baylor said in a conference call with reporters yesterday. “We do see a decline in potency every now and then.”

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Sanofi: Non-Safety Related Recall Of 800K Doses Of Vaccine

 

 

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This morning we’ve an announcement from the CDC and Sanofi Pasteur, on the recall of 800,000 doses of pediatric single-dose syringes of the H1N1 vaccine due to concerns over potency.

The CDC states that there are NO SAFETY CONCERNS regarding this vaccine, but that it tested to be less potent than specified. 

 

Bloomberg News is just one of the outlets with this story.  An excerpt, then a visit to the CDC’s Q&A page on this recall.

 

 

Sanofi Recalls 800,000 Swine Flu Shots on Potency (Update1)

By Tom Randall

Dec. 15 (Bloomberg) -- Sanofi-Aventis SA recalled 800,000 doses of swine flu vaccine after testing showed the potency of the batches was too low, the U.S. Centers for Disease Control and Prevention said in a statement today.

 

Doctors who have unused shots from the batches should return them, the CDC said today. The shots remain safe, and people who have already been inoculated don’t need to get revaccinated, according to the Atlanta-based agency.

 

The shots passed potency tests when they first shipped, and their potency dropped in subsequent tests by 10 to 12 percent, said Anne Schuchat, head of the National Center for Immunization and Respiratory Diseases at the CDC, in a telephone interview.

 

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The CDC’s  Q&A page on this recall.  Follow the link to read it in its entirety.

 

 

Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes Questions & Answers

December 15, 2009, 9:00 AM ET

Why are some lots of pediatric H1N1 vaccine manufactured by Sanofi Pasteur in pre-filled syringes being recalled from the market?

As part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time. It is performed because sometimes the strength of a vaccine can go down over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (called a “lot”) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. This means that doses from these four vaccine lots no longer meet the manufacturer’s specifications for potency. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots.

What does potency mean for the H1N1 vaccine?

Potency (or strength) is determined by the measurement of the concentration of the active ingredient (also called antigen) in the H1N1 vaccine.

Are there any concerns about safety of vaccines from these lots?

No. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety.

Should infants and children who received vaccines from these lots be revaccinated?

No. The vaccine potency is only slightly below the “specified” range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen. There is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

What action(s) should parents of children who have received vaccine from the recalled lots take?

Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed.

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