Johnson and Johnson subsidiary, McNeil Consumer Healthcare has issued a voluntary recall of 43 Tylenol brand children and infant products, including Concentrated Tylenol Infant Drops, Children’s Motrin, Children’s Zyrtec, Benadryl, and other over-the-counter products.
The recall was triggered by what the FDA calls “manufacturing deficiencies” that affect the quality, purity or potency of the drugs, says the FDA in a news release.
The problem, according to the FDA notice, is that some products may contain a higher concentration of the active ingredient while others may not have active ingredients and “may not meet internal testing requirements; and others may contain tiny particles.”
The FDA notice says nothing about consumers returning products for a full refund but that is customary.
FDA inspectors notice the problem during a routine inspection April 19 at the J & J Fort Washington, Pennsylvania manufacturing plant.
Douglas Stearn, a senior FDA official said the manufacturing process was “not in control," another way of saying it was out of control.
How long have problems been ongoing? Stearn indicated that this may have been going on for some unspecified time - “This does go back in time" and that "we have to try to figure that out."
McNeil and the FDA say the potential for injury is remote and the recall is not being initiated because of any adverse reactions. McNeil has reportedly received consumer complaints concerning some of the recalled medicines, according to the Washington Post.
Consumers are advised to discontinue use and McNeil is offering coupons to replace the products on their Web site.
Children should not be given an adult formulation.
The medications were distributes in the U.S. and Canada, the Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait.
This is the third recall of McNeil products since 2008.
In January, Tylenol Extra Strength, Benadryl, Motrin and Rolaids were recalled because of a musty odor. Last November McNeil recalled five lots of Tylenol Arthritis Pain 100 count with the EZ-Open cap. The recall was expanded further in December to include all lots of Tylenol Arthritis Pain Caplet with the EZ-Open cap.
At that time, some consumers had complained about stomach problems. A chemical substance called 2,4, 6-tribromoanisole (TBA) is applied to wood pallets and the chemical breakdown was transferred to packaging materials.
The FDA has traced the pallets to a manufacturing plant in Puerto Rico. The agency is determining whether other drug makers also use pallets from this plant to transport products. #