Over-The-Counter Antihistamine Recalled For Lack Of Child-Resistant Closure

Description

August 13, 1992 Release # 92-125 Over-The-Counter Antihistamine Recalled For Lack Of Child-Resistant Closure PRODUCT: "Valumed Diphenhydramine Hydrochloride," 25 milligram capsules in 100 capsule bottles manufacturered by Contract Pharmacal and soley distributed by Moore Medical Corporation. PROBLEM: 11,000 bottles of the product were distributed nationwide without required child-resistant closures. This medicine could cause serious health problems or death to a child who swallowed several of the capsules. WHAT TO DO: Immediately return the product to the store where purchased for a refund. WASHINGTON, DC - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Moore Medical Corp. of New Britain, CT is voluntarily recalling 100 capsule bottles of "Valumed" Diphenhydramine Hydrochloride (HCl) 25 milligram (mg) capsules manufactured by Contract Pharmacal of Hauppauge, NY. The drug is not packaged in child-resistant packaging as required under the Poison Prevention Packaging Act (PPPA). The product is marketed as an antihistamine. This medicine could cause serious health problems or death to a child who accidentally swallowed several capsules. The recalled product contains 100 capsules with a total of 2500 mg of Diphenhydramine HCl per bottle. CPSC enforces the PPPA requirement that any over-the-counter medication containing more than the equivalent of 66 mg Diphenhydramine base in a single container must be supplied with child-resistant packaging. Moore Medical Corp. reported the packaging problem and initiation of this recall to CPSC. Consumers should immediately return the product to the store where purchased for a refund of the purchase price. Moore Medical Corp. distributed 11,000 of the bottles from November 1991 to mid-May 1992. They were distributed to 171 independent pharmacies, 214 chain drug stores, and 606 professional accounts (doctors, schools, nursing homes, etc.) nationwide, including Puerto Rico. Moore Medical Corp., the sole distributor of "Valumed" drug products, instituted the recall of this product, which was manufactured by Contract Pharmacal, because of its potential toxicity hazard to children due to the lack of child-resistant packaging. Neither the recalling firm nor the Commission is aware of any poisoning incidents due to the non-child-resistant packaging of this product. CPSC is announcing this recall as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. The Commission's objective is to reduce the estimated 28.5 million injuries and 21,600 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction