Over-the-counter medicine company Reese Pharmaceutical has received a warning letter from the U.S. Food and Drug Administration, which alleges manufacturing and labeling violations.
The letter lists four specific violations found during an FDA inspection of Cleveland-based Reese’s manufacturing facility in November. For example, the company failed to thoroughly investigate the reason behind the mislabeling of bottles of cold decongestant tablets, according to the warning letter.
Warning letters are considered by the FDA to be informal and advisory, and don’t necessarily indicate that the FDA intends to take any punitive action against recipients. The FDA asked Reese to respond within 15 days with a list of the steps it plans to take to correct the violations.
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The FDA letter was addressed to George Reese, the company’s president, who didn’t immediately return a call.
Reese sent a response letter to the FDA after the agency uncovered the violations, but the FDA repeatedly labeled the response as “inadequate.” For example, the FDA alleges that Reese failed to evaluate discrepancies found between the quantity of drug product finished and the quantity of labeling issued.
“Your response, however, is inadequate because you fail to provide an adequate and specific corrective action plan regarding how your firm will reconcile the labeling,” the warning letter states.
Reese was founded in 1907 and produced the Dough Boy Prophylactic Kit for U.S. soldiers in World Wars I and II. The company now makes a variety of OTC products, including cough and cold tablets, topical creams and ointments, and dietary supplements.
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The company says its most popular and recognized product is “Reese’s Pinworm Medicine,” which is used to treat infections caused by a type of intestinal parasite.
