If you currently have any liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec® or Benadryl® products, check this recall notice and stop using any of the products listed.
McNeil Consumer Healthcare, a division of McNeil-PPC, Inc. and part of the Johnson & Johnson Family of Companies has announced a voluntary recall of 43 children’s and infant’s over-the-counter medications distributed to thirteen countries due to quality issues.
The recalled products include certain liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl products. McNeil manufactured these medications in the United States and distributed them in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait. For a complete list of recalled products, please see the recall notice.
Some of the recalled medications contain higher concentrations of the active ingredient that in listed on the label, while others may contain inactive ingredients that do not meet internal testing requirements or also may contain tiny particles.
The company says no adverse medical incidents have occurred, calling the potential for serious medical events “remote.”
“The company is 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,” McNeil said in a release.
Parents or caregivers should not use these recalled medicines and according to the U.S. Food and Drug Administration (FDA), should turn to other products on the market such as generic equivalents. The FDA warned against substituting an adult medication, that adult medication use in infants or children could result in serious harm.
“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,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. in an FDA 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.”
According to an article in The Washington Post, this recall was triggered when FDA inspectors saw “manufacturing deficiencies” during a routine inspection of the company’s Fort Washington, PA plant on April 19.
McNeil Consumer Healthcare has experienced quality control issues.
In March 2010, McNeil recalled certain lots of Children’s Tylenol and Children’s Zyrtec after finding that some product bottles purchased from an external supplier did not meet specifications because plastic areas of the bottle were “thin-walled,” possibly effecting stability of the product over time due to increased exposure to light.
In January 2010, McNeil recalled an extensive list of 49 Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Josephs products due to an unusual moldy, musty or mildew-like odor caused by the degrading of a chemical treating the wood pallets used to transport and store product packaging materials. It caused incidences of nausea, stomach pain, vomiting and diarrhea.
In September 2009, McNeil recalled Children’s and Infants’ Tylenol® liquid products, stating that the recall was due to an inactive ingredient that did not meet all quality standards. A letter to healthcare professionals detailed the recall was actually attributed to a bacteria, Burkholderia cepacia (B. cepacia), detected in bulk raw material.