The procedural review conducted in consultation with the Food and Drug Administration, the recall involves certain batches of Tylenol 8 hour Tylenol Arthritis Pain and Tylenol upper respiratory products, and some Benadryl, Sudafed PE Sinutab and products.
The latest Tylenol recall comes after a review of McNeil Fort Washington plant, which was closed due to its continued production problems since early May, found equipment cleaning procedures were inadequate or that the cleaning was not documented properly. On Wednesday, Oregon became the first state in the US to file a lawsuit against J & J over a alleged “phantom” recall of Motrin drugs. The suit alleges that the company’s McNeil division sold faulty Motrin drugs in gas stations and convenience stores nationwide in 2008, and then secretly removed the products from the store shelves later.
It is “very unlikely” that the product quality was affected and consumers or providers of health care require no action. Consumers can continue using the product, Johnson & Johnson said in a statement. This recall affects over 45 million products, a spokeswoman for the company said.
The drugs were produced by the ailing enterprise division McNeil, who was sued for over a year by a series of recalls and critical control actions by the Food and Drug Administration and federal legislators.
Wednesday, Oregon became the first state to file a complaint against J & J on a “ghost” recall drug Motrin.
The lawsuit alleges that the division of McNeil Motrin sold defective drugs in gas stations and convenience stores in 2008 and secretly removed the products from store shelves.
On Friday, CNNMoney had learned that a multi-state investigation into J & J’s handling of drug recalls is under way.
People familiar with the investigations confirmed the validity of the probes. At least 14 states are involved in the latest effort, according to one source. Johnson & Johnson declined to comment as of this writing. The Tylenol recall Friday was the latest in a series troubling the manufacturer McNeil.