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"Valumed Diphenhydramine Hydrochloride," 25 milligram capsules in 100 capsule bottles manufacture...

CPSC Recall #92-125 - August 12, 1992

Recall Summary

Recall Number92-125
Recall DateAugust 12, 1992
Remedy TypeRefund
Units Affected100 capsule bottles

Product

"Valumed Diphenhydramine Hydrochloride," 25 milligram capsules in 100 capsule bottles manufactured by Contract Pharmacal and solely distributed by Moore Medical Corporation

Description

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.

Hazard

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.

Remedy Instructions

 Immediately return the product to the store where purchased for a refund.

What Should You Do?

Stop using this product immediately. Contact the manufacturer for a Refund at no charge. If you experienced an injury, report it at SaferProducts.gov.

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Frequently Asked Questions

Follow the consumer action instructions in the recall notice above. Most recalls require you to stop using the product and contact the manufacturer directly, either by calling the toll-free number listed in the official CPSC notice or by visiting the manufacturer's website. You generally do not need a receipt or original packaging to claim a remedy. The manufacturer is legally required to provide the remedy (Refund) at no cost to you.

Yes. If you were injured by a defective consumer product, whether recalled or not, you may have grounds for a product liability claim against the manufacturer and potentially the retailer. A recall notice can serve as evidence that the manufacturer was aware of the defect. Injuries that may support a claim include burns, lacerations, fractures, electric shock, choking incidents, and chemical exposure. Most product liability attorneys work on a contingency fee basis, meaning you pay nothing unless you win. Consult an attorney promptly, as statutes of limitation vary by state.

In most cases, no. CPSC-coordinated recall remedies are designed to be accessible without proof of purchase. Manufacturers typically ask consumers to self-certify ownership and may ask for photos of the product or its serial number. Some manufacturers request that you mail in a portion of the product (such as a cut cord or removed component) as proof of disposal. Check the specific remedy instructions for this recall for exact requirements. If you registered your product at the time of purchase, the process is usually even simpler.

If the original manufacturer has gone out of business, the recall remedy may no longer be available through them. In this case, contact CPSC directly at 1-800-638-2772 or cpsc.gov for guidance. If the brand was acquired by another company, the acquiring company may have assumed recall obligations. In some cases where a remedy is unavailable, CPSC advises consumers to safely dispose of the product. If you were injured by the product of a defunct company, consult a product liability attorney, parent companies, distributors, and retailers may still bear liability in some circumstances.

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