Johnson & Johnson (JNJ) recalled nearly 47 million units of over-the-counter medicines Friday, the latest in a string of quality-related product recalls.
J&J said the latest recall resulted from a thorough examination of historical manufacturing records that the company had undertaken in the wake of earlier recalls. J&J plans to continue reviewing practices at additional manufacturing sites and signaled further recalls could result if more issues surface.
The New Brunswick, N.J., company said it was recalling 42.9 million bottles of certain Tylenol, Benadryl, Sudafed and Sinutab products distributed in the U.S., the Caribbean and Brazil.
J&J said these products were made at its McNeil Consumer Healthcare plant in Fort Washington, Pa., prior to April 2010, when production was suspended. J&J said it reviewed past production records and found cases where equipment cleaning procedures were insufficient, or cleaning wasn't adequately documented.
J&J said it was "very unlikely" these issues affected the quality of the recalled products.
In addition, J&J recalled 3.9 million bottles, rolls and packages of Rolaids antacid distributed in the U.S., to update the product labeling. The company said the labeling didn't include a notice that the product wasn't tested by U.S. Pharmacopeia, which is a non-governmental testing method for medicines. The Food and Drug Administration doesn't require the use of USP, but labels on products that don't use this testing are required to include the language "Does not meet USP," said McNeil spokeswoman Bonnie Jacobs.
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