NEW YORK (MarketWatch) -- Pharmaceutical giant Johnson & Johnson Inc. has initiated a voluntary recall of liquid Tylenol, Motrin and other over-the-counter drugs for children and infants because of 'manufacturing deficiencies' in its Port Washington, Pa. plant that may affect quality, purity or potency of the drugs.
The company, in conducting a self assessment before the Food and Drug Administration's routine inspection, informed the FDA of its voluntary recall, said Bonnie Jacobs, a spokeswoman for J&J's McNeil Consumer Healthcare unit that's conducting the recalls.
She said there have been no reported injuries or hospitalizations and that the company's initiating the recall not "on the basis of adverse medical events."
She declined to comment on the possible cost of the recall for the company and said the recalled products are limited to those made at a Pennsylvania plant. She declined to specify other manufacturing facilities that Johnson & Johnson owns.
"We will begin manufacturing after we've implemented the corrective action," she said.
Products recalled also include certain liquid infant's and children's Zyrtec and Benadryl products, the FDA said.
J&J said it's initiating the voluntary recall because some of these products may not meet required quality standards. The products were distributed in the U.S., Canada, Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait, the company said in a statement.
It said some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
While the potential for serious medical events is remote, FDA said consumers should discontinue use of these recalled products.
"We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product," FDA Commissioner Drugs Margaret A. Hamburg said in a press release. "While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more."
The company also said it's conducting a "comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made."
Johnson & Johnson /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 64.30, -0.71, -1.09%) shares fell 1.1% to $64.30 on Friday.
Andria Cheng is a MarketWatch reporter based in New York
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