CPSC, Private Formulations Inc. Announce Revco Brand Pain Reliever Recall

WASHINGTON, DC - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Private Formulations, Inc., the manufacturer of Revco Brand Pain Reliever and Revco D. S. Inc., of Twinsburg, Ohio, are voluntarily recalling approximately 7,000 bottles of Revco Brand Pain Reliever. The pills, which contain 500 milligrams of the painkiller acetaminophen and are sold in bottles of 500 caplets, were not packaged in child-resistant containers as required by the Poison Prevention Packaging Act.

Private Formulations, Inc., Revco D. S. Inc. and CPSC are not aware of any poisoning incidents involving these caplets. While the medication itself is not contaminated, the lack of child-resistant packaging means that a child could easily open the package and accidentally swallow the pills. The ingestion of as little as 150 milligrams/kilogram or four caplets of this painkiller has been associated with liver damage in children under five years of age.

The product was sold to consumers through Revco Drug Stores in Georgia, Maryland, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, and West Virginia between November 1, 1994, and November 10, 1994, for about $11 per bottle.

Revco is recalling bottles with the number ZB4K046D or ZB4K010D printed vertically on the right hand edge of the label together with the expiration date. This recall does not include any other sizes of bottles, forms of acetaminophen-containing products, or labels with other numbers distributed by Revco D.S., Inc.

Consumers should immediately return the unused portions of any bottles of the recalled Revco Brand Pain Reliever to any Revco Drug Store for a refund of the purchase price or replacement with a complying product, or call Revco D. S. Inc. at (800) 777-3826 between 9 a.m. and 5 p.m. EST, Monday through Friday, for instructions on where to send the recalled products for a refund, including shipping costs.

CPSC became aware of the packaging problem as a result of Revco D.S. Inc. filing a report with the Commission. CPSC enforces the requirement that any over-the-counter medication containing an equivalent of more than 1,000 mg of acetaminophen per package must have child-resistant packaging.