More Headaches for McNeil HealthCare and Johnson & Johnson

The FDA has reported growing concerns over the manufacturing quality of McNeil Consumer HealthCare’s facilities. McNeil, the producer of many over-the-counter medications, has been frequently cited for unsatisfactory inspections. In February of this year, both McNeil Consumer HealthCare and Johnson & Johnson, McNeil’s parent company, were warned by the FDA to correct the problems noted by FDA investigators.

On April 30th, 50 different over-the-counter medications for children and infants were recalled. This recall involved over 136 million bottles of liquid Tylenol, Benadryl, Zyrtec and Motrin. The raw products used in the liquid medications were found to contain gram negative bacteria (B. cepacia). The finished products that were tested did not contain any of these organisms. The involved medications may also contain higher concentrations of active ingredients, small particles and some in-active ingredients which have not passed testing requirements. Last year, McNeil failed to investigate reports of a musty odor at the plant where Tylenol Arthritis is manufactured. It took over a year for the company to investigate the origin of the odor which was later linked to a pesticide used on the wood where empty bottles were stored.

Both McNeil and the FDA state “the potential for serious medical events is remote” and both are urging consumers to trash all medication involved in the recall. To contact the McNeil Consumer HealthCare, visit their website or call them at 1-888-222-6036. Be sure to report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting:
•To report online, click here.
•To report via regular mail, complete this formand mail to:
MedWatch
FDA
5600 Fishers Lane
Rockville, MD 20852-9787
•To report via fax, complete this form and fax to 1-800-FDA-0178

Do not replace children and infant medications with adult medications and seek generic versions of the involved medication when possible. If you are not sure of an appropriate alternative, consult your healthcare provider or local pharmacist.

Until further notice, the Fort Washington plant in Pennsylvania has voluntarily shut down production and will not resume production until the FDA is notified. Due to the recent recalls at the Fort Washington plant, Blacksmith Brands issued a voluntarily recall on four PediaCare Children’s products on May 29th as a precautionary measure. The following products are included in this recall:
•PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
•PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
•PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
•PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

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Babies 411 is an on-line information and resource center for parents. This site has been developed by a neonatal intensive care nurse with the sole purpose of promoting the health, safety, and well-being of all babies.

Author : Diba Tillery RN, BSN, IBCLC, CPST