Johnson and Johnson, FDA Recall Some Children's Pain and Allergy Meds
Late on Friday, April 29, Johnson & Johnson and McNeil Consumer Healthcare announced a recall of several of their products, including liquid infant's and children's Tylenol, Motrin, Zyrtec, and Benadryl. A statement from FDA Commissioner Dr. Margaret Hamburg urged consumers to discontinue using the recalled products.
According to a report by Reuters, Hamburg's statement also said the potential for health problems to be caused by the recalled drugs is remote, however, "Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more," she said.
The recalled products were manufactured by McNeil Consumer Healthcare. The company has posted a full list of the affected products on its website which you can visit by clicking here.
According to the FDA press release, McNeil Consumer Health Care initiated the recall because some of the products may not meet required quality standards. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements and others may contain tiny particles. The FDA is asking parents and caregivers to discontinue using these products. The generic versions of the products are not affected by the recall and are safe to use.
If a child has any adverse affects after using any of the recalled products, parents and caregivers can report the problems to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. The FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at: http://www.fda.gov/Safety/MedWatch/ucm2005699.htm.
Consumers with questions about the recall can contact the company at 1-800-222-6036 or visit the website at: http://www.mcneilproductrecall.com/.
- Johnson & Johnson's recalls infant, children's Tylenol, Motrin (Reuters)
- FDA News Release regarding the product recall (FDA)
- How to Get Your Tylenol Refund (New York Times)
- Drugs and Medical Device Recalls (FindLaw)
- Defective and Dangerous Products - Resources (FindLaw)
- Defective Drugs (provided by Blizzard, McCarthy & Nabers)
- Product Liability FAQ (provided by Harris Penn & Lowry, LLP)