NEW YORK — Pharmaceutical giant Johnson &Johnson Inc. has initiated a voluntary recall of liquid Tylenol, Motrin and other drugs for children and infants because of manufacturing deficiencies that may affect quality, purity or potency of the drugs, the Food and Drug Administration said Saturday.
Products recalled also include certain liquid infant’s and children’s Zyrtec and Benadryl products, the FDA said.
The McNeil Consumer Healthcare unit of J&J is initiating the voluntary recall because some of these products may not meet required quality standards, the FDA 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, the FDA said.
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 Hamburg said. “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.”
Johnson &Johnson shares fell 1.1 percent to $64.30 on Friday.
Meanwhile, The Associated Press reports that the FDA is reviewing procedures at McNeil, which appears to be the sole source of the problems. “We are following through with the facility to make certain that everything has been checked,” said FDA spokeswoman Elaine Gansz Bobo.
The FDA said a health care professional should be consulted if a child has recently taken any of the recalled products and is exhibiting unexpected symptoms.
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