FDA: No shortage of children's medications; Johnson and Johnson widens recall

July 20, 2010

FDA said on June 25 that it does not expect any shortage of children?s pain and allergy medications, despite Johnson & Johnson?s inability to resume production until at least next year, Reuters reported.

FDA said on June 25 that it does not expect any shortage of children’s pain and allergy medications, despite Johnson & Johnson’s inability to resume production until at least next year, Reuters reported. The company produces an estimated 70% of liquid over-the-counter (OTC) medications for children.

“There are many alternative products available, including generics, and we do not anticipate a shortage in supply,” FDA spokeswoman Elaine Bobo told Reuters.

Separately, Johnson & Johnson announced on July 8 a further recall of 21 additional product lots of OTC medications such as Benadryl, Motrin, and Tylenol, which were overlooked in its original product recall in January. The product lots involved in the latest recall are 2 lots of Benadryl Allergy Ultratab tablets, 100 count; 16 lots of Tylenol caplets, tablets, meltaways, and gelcaps; and 3 lots of Motrin caplets and tablets. The products were sold in the United States, Fiji, Guatemala, Dominican Republic, Jamaica, Trinidad and Tobago, and Puerto Rico.

In January, McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalled 49 adult Tylenol products and 2 children’s products.

In June, McNeil announced that it did not expect to resume production of most consumer medicines made at its Fort Washington, Pa. plant before the end of the year. The plant shut down in late April when the company announced a widespread recall of infants’ and children’s liquid OTC products produced there.

U.S. inspectors found filthy equipment and contaminated ingredients at the factory, which also manufactured the pain medicine Motrin and allergy drugs Benadryl and Zyrtec.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before manufacturing resumes in Fort Washington. McNeil has not yet finalized plans for resumption of production at the facility.

“FDA continues to monitor the situation, and we are in continuous communication with McNeil Consumer Healthcare regarding start-up of production at the Fort Washington plant,” Bobo said.

The recall has prompted a congressional investigation.