Tylenol Recall

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On February 17, 2012, McNeil Consumer Healthcare voluntarily recalled seven lots of Infants' Tylenol® ® Oral Suspension, 1 oz. Grape. Roughly 574,000 bottles were affected, due to faulty dosage systems. Some consumers complained that it was hard to use the Tylenol SimpleMeasure™ system, which consists of a syringe to be dipped into a "flow restricter" cover. Some users reported that this cover pushed into the bottle when trying to fil the syringe. The recall is strictly a precautionary measure, and no adverse events have been reported. However, parents are cautioned not to use the medicine if the cover is pushed into the bottle. Consumers may request a refund through the McNeil product website.[1]

In August 2011, McNeil Consumer Healthcare voluntarily recalled 15 lots of Tylenol® Cold Multi-Symptom Nighttime Rapid Release Gelcaps due to elevated levels of Chlorpheniramine Ammonio Acetate (CPAA). No health risks are expected.[2] Concerned customers may contact the McNeil Consumer Healthcare Center at (888) 222-6036 from Monday through Friday between 8 a.m. and 8 p.m. Eastern time and from 9 a.m. to 5 p.m. on Saturdays and Sundays.[3]

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Tylenol.jpg

Flickr: sydusa
Date of latest recall February 17, 2012[1]
Originally released 1955[4]
Treats Mild to moderate pain relief, fever reduction, allergies, colds and flus (varies by product)[5]
Administration Taken by mouth as directed on product package
Reason for latest recall Faulty packaging causes cover to be pushed into bottle when filling included syringe
Disclaimer The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Susan MacDowell
 
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Contents

Tylenol® Recall Timeline

February 17, 2012: McNeil Consumer Healthcare recalled seven lots of Infants' Tylenol® Oral Suspension, 1 oz. in grape flavor. There are no health threats, but consumers are advised to return the product if the cover gets pushed into the bottle. The affected lot numbers are BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00, and the UPC code is 300450122308. Customers who want a refund can call McNeill directly at 1-888-222-6036 or visit the company website. If there are any negative reports regarding the safety of this product, consumers may contact the FDA through their online MEDWATCH program or can fax a report to 1-800-FDA-0178.[1]

August 15, 2011: McNeil Consumer Healthcare issued a recall for certain packages of Tylenol® Cold Multi-Symptom Nighttime Rapid Release Gelcaps due to higher-than-normal levels of chlorpheniramine ammonio acetate (CPAA), which the company says is not likely to cause harm. Affected packages include Tylenol® Cold Multi-Symptom Nighttime Rapid Release Gels 24 RR Gelcaps, lot numbers AMA277, APA059, APA162, ASA025, APA237, ASA072, ASA208, BAA008, with UPC code 300450395245; Tylenol® Cold Multi-Symptom Rapid Release Gels Day/night 12+8 RR Gelcaps, lot numbers AMF034, BAF005, BAF027, BCF080, UPC code 300450396204; and Tylenol® Cold Multi-Symptom Rapid Release Gels Day/night 36+24 RR Gelcaps, lot numbers BBF001, BCF060, BCF079, UPC code 300450396600.[2]

June 28, 2011: 225-count bottles of Tylenol® Extra Strength Caplets, lot number ABA619, UPC code 300450444271 were added to the list of products recalled for musty odor. The pills were manufactured at the now-closed Fort Washington, PA plant in February, 2009. Those who had purchased these caplets were advised to discontinue use and report to McNeil Consumer Healthcare for refund information.[2]

July 8, 2010: An additional 21 lots of Benadryl® Allergy Tablets, Motrin® IB Caplets and Tylenol® Tablets, Caplets and Geltabs were recalled in an expansion of the prior recalls due to musty odor complaint. Lot numbers include: ABA567, ABA574, ABA544, ACA003, ACA002, AFA060, ASA206, ABA005, ABA566, ACA025, AFA018, ABA168, ABA168, ACA024, AJA119, ACA005, ADA259, AFA100 and ACA004.

June 2010: McNeil Consumer Healthcare issued a voluntary recall to include lot number ASA202 of Tylenol® Extra Strength Rapid Release Gel Caps, as well as four lots of Benadryl Allergy Ultratab tablets. This is directly related to prior recalls stemming from complaints of a "musty odor" in the bottle's containers.[2]

May 2010:The 2009 recalls resulted in the Johnson & Johnson Fort Washington, Pennsylvania plant, operated by subsidiary McNeil Consumer Healthcare, receiving Form 483 reports and a warning letter prior to its shutdown in early May 2010. A Form 483 is issued when an FDA inspection yields unsatisfactory results for regulatory compliance or violations of good manufacturing practices. McNeil has since begun an overhaul of the facility to bring it up to FDA standards. Meanwhile, another Johnson & Johnson plant, located in Lancaster, Pennsylvania, was issued form 483s for failure to pass an FDA inspection. The Lancaster facility manufactures non-prescription products such as heartburn relievers Mylanta and Pepcid, and multi-symptom relief drug Imodium[6]

April 2010: Children’s Tylenol® and Zyrtec®, as well as additional lots of Motrin® and Benadryl® were voluntarily recalled by the manufacturer due to tiny metal particles in the products, and more of the active ingredient than specified on the package label. Over 50 products were included in the April 30th recall. Johnson & Johnson cautioned that special care be taken with the children's products.[2][7]

March 2010: Lots of Infants' Tylenol®, Infants' Motrin®, and Children's Zyrtec distributed to United States wholesalers were recalled due to the potential for the product lot numbers and expiration dates printed on the bottles to become illegible as a result of consumer handling. Additional lots were recalled due to the bottle plastic being thinner than required by company standards.[2]

January 14, 2010: Multiple over-the-counter Johnson and Johnson products were recalled on January 14, 2011.[8] Affected lots of Tylenol® 8-Hour, Tylenol® Arthritis Pain, Tylenol® Cold, Tylenol® Allergy, Tylenol® Sinus, Benadryl®, Sinutab® Sinus, Sudafed PE® and Rolaids® were manufactured at the McNeil plant in Fort Washington, Pennsylvania prior to suspension of production in April 2010. The reason listed for the recall is insufficient cleaning of production equipment or inadequate documentation of equipment cleaning. The affected lots were distributed within the United States, the Caribbean, and Brazil. Because the recall is being issued at the wholesale level, action is not required by consumers. The company does not believe that the quality of the drugs was affected.

The recall was later expanded to include product lots of Tylenol® caplets and gelcaps, both rapid and extended release varieties. Product lots of Motrin, Benadryl, St. Joseph's Aspirin and chewable Rolaids were also included in the January 2011 recall expansion.[2]

December 2009: The November 2009 recall was expanded to include more units of the same product within the Tylenol® brand. Consumers were advised to stop using any of the product lots within the recall. Anyone with a defective product was encouraged to contact the manufacturer for a refund or replacement product.[2]

November 2009: 100-count bottles of Tylenol® Arthritis Pain Caplets with red "EZ-Open" caps were recalled after a chemical found in wooden pallets involved in the products' storage and transportation began breaking down and causing an "unusual moldy, musty, or mildew-like odor".[9] Consumers of the products with this noticeable odor later experienced various digestive tract disorders, including nausea, vomiting or diarrhea. Johnson & Johnson released a statement indicating that the effects were mild and temporary.[2]

2008: Several varieties of Tylenol® products manufactured between April and June of 2008 were recalled after raw materials produced at the same location and time as inactive ingredients were determined to contain a harmful bacteria. Although bacteria were not found in the finished products, Johnson & Johnson erred cautiously imposed avoluntary recall as a precautionary measure.[10]

1982: Seven Chicago area residents died as a result of consuming Extra Strength Tylenol® products that had been laced with cyanide. The perpetrator was never caught. However, the incident led to industry-wide safety initiatives including tamper-resistant caps and the gelcap.[11]

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About Tylenol®

While the analgesic properties of acetaminophen, the active ingredient in Tylenol®, were discovered during the 19th century, it was not until the mid-20th century that scientists deemed the drug a safe and effective pain relief product. Tylenol® was introduced in 1955 as a prescription competitor to aspirin for pain relief.[4] The first Tylenol® product introduced, Elixir Tylenol®, was a liquid children’s medicine that was used to reduce pain and fever. Its marketing campaign depicted a cartoon fire engine with the slogan "For little hotheads." While more expensive than aspirin, Tylenol® did not cause the same stomach upset. It was later approved in 1960 for over the counter distribution.

While Tylenol® is a common over the counter analgesic and fever reducer, it has been known to cause liver damage when more than the recommended dosage is taken.[12] An FDA advisory committee voted to decrease the recommendation for a single adult dose of acetaminophen to 650 milligrams, as opposed to the current 1,000 milligrams contained in two tablets of over-the-counter pain products. The same panel also agreed that the total maximum 24 hour dosage should be decreased from the current recommended dosage of 4,000 milligrams per 24 hour period.

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Taking Acetaminophen Safely

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Also See: Tylenol and Pregnancy, Tylenol Coupons, Tylenol Side Effects, Motrin Recall, Zyrtec Side Effects, Zyrtec Coupons, Aspirin Coupons, Benadryl Coupons, Caltrate Coupons, Benadryl Recall, Drug Side Effects, Acetaminophen, Motrin, Sudafed Coupons, Rolaids, Novartis Recall

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References

  1. 1.0 1.1 1.2 http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_8.inc
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_7.inc
  3. http://mcneilproductrecall.com/
  4. 4.0 4.1 http://www.nytimes.com/2010/06/04/business/04mcneil.html
  5. http://www.tylenol.com/
  6. http://money.cnn.com/2010/07/16/news/companies/johnson_fda_new_inspection_report/
  7. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210441.htm
  8. http://www.mcneilproductrecall.com/page.jhtml?id=/include/news_jan_2011.inc
  9. http://www.webmd.com/news/20091229/tylenol-recall-expands
  10. http://latimesblogs.latimes.com/booster_shots/2009/09/some-explanation-if-you-look-for-it-on-the-childrens-tylenol-recall.html
  11. http://www.usatoday.com/news/health/2007-09-29-tylenol-poisonings_N.htm
  12. http://www.medicinenet.com/script/main/art.asp?articlekey=101619