The recall affects 667,632 packages, according to Bloomberg, which first reported the recall. McNeil is recalling, at the wholesale level in the U.S., the over-the-counter allergy and cold medicine Sudafed 24 Hour Extended-Release Tablets (10-count packs, 240 mg each) because the instructions repeat the word "not" as follows: "do not not divide, crush, chew, or dissolve the tablet."
The internal packaging contains the proper instructions: "swallow each tablet whole; do not divide, crush, chew, or dissolve the tablet." The company further says in its statement: "To date there have been no reports of adverse events caused by this labeling error."
In a previous Sudafed recall in January, which was part of a larger one, the company said it had found insufficient equipment cleaning procedures on the production line. "McNeil identified the inadequacies as part of a thorough, proactive quality and process assessment of all McNeil produced products," the company said in a statement.
A String of Recalls That Started in 2009
The largest consumer health care company's recall woes began in 2009. In April 2010, J&J initiated a huge recall of over-the-counter children's medicines, such as Tylenol and Motrin, because of manufacturing deficiencies that affected the quality, purity and potency of the products. These recalls were the subject of two Senate investigations, and the Oversight Committee hearings revealed cover-ups and phantom recalls.
In response, J&J suspended manufacturing at its Fort Washington, Penn., plant, made changes at a plant in Puerto Rico, and has been conducting a complete review of its products, leading in some cases to further recalls. It was expected that as the product reviews proceeded, there might be additional recalls.
On top of the investigations by regulatory bodies and lawmakers, loss of confidence by consumers and investors alike, J&J also said the recalls cost $900 million in sales last year. The company that was once a symbol of quality -- in product, business and management -- is becoming a caricature of itself.