The U.S. Consumer Product Safety Commission, in cooperation with Altaire Pharmaceuticals and Rugby Laboratories, has announced a voluntary recall of Rugby Children’s Pain & Fever Concentrated Drops. The over-the-counter medication fails to meet requirements for child-resistant packaging, meaning children could access the medicine without supervision, posing serious health problems or death if more than the recommended dosage is consumed.

This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate dropper unit provided for dispensing the drug to children does not.

The recall includes about 898,000 units of the Rugby Children’s Pain & Fever Concentrated Drops (Acetaminophen Drops) in a 1/2 fl. oz. (15 ml) bottle size. The UPC code 305361936723 can be found with the bar code at the bottom of the box. The affected lot numbers are:

The lot numbers can be found stamped into the bottom of the carton with the expiration date, and above the label on the bottle printed in black. This product was sold at drug stores, grocery stores and other retailers nationwide between January 2009 and June 2011 for about $4.

For additional information, contact Rugby Laboratories at (800) 645-2158 between 9 a.m. and 5 p.m. ET Monday through Friday.