(301) 504-0580 Ext. 1193
|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.
The U.S. Consumer Product Safety
Commission protects the public from the unreasonable risk of injury or death from 15,000
types of consumer products under the agency's jurisdiction. To report a dangerous product
or a product-related injury and for information on CPSC's fax-on-demand service, call
CPSC's hotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270. To order a
press release through fax-on-demand, call (301) 504-0051 from the handset of your fax
machine and enter the release number. Consumers can report product hazards to firstname.lastname@example.org.