Rugby Children’s Medication Recall: Tops Not Child-Resistant

Due to inadequate child-resistant packaging, nearly 900,000 bottles of Rugby Children’s Pain & Fever Concentrated Drops have been recalled nationwide. 

The U.S. Consumer Product Safety Commission (CPSC) announced the Rugby children’s pain medication recall on June 23. The drops are manufactured by Altaire Pharmaceuticals, Inc., based in Aquebogue, New York, and distributed by Rugby Laboratories, Inc. of Duluth, Georgia.

According to the CPSC, the pain and fever drops come with a bottle and a dropper unit with a screw-on cap. The original bottle has child-resistant features, but the dropper unit, which can be used in place of the original cap, does not. This means that if the dropper unit is being used as the cap, a child can unscrew it and access the medicine. There have been no injuries reported in relation to the non-child-resistant bottles.

Rugby Children’s Pain & Fever Concentrated Drops contain acetaminophen. All acetaminophen products are required to have child-resistant packaging under the Poison Prevention Packaging Act.

Acetaminophen, the generic name for Tylenol, is a pain killer and anti-inflammatory medication found in a number of over-the-counter and prescription drugs. In recent years, federal regulators have become concerned over the frequency of its use in a variety of medications. Overuse of the drug could lead to liver injury and other health problems, according to the FDA.

Earlier this year the FDA placed new limits on acetaminphen’s use in other, more powerful, painkillers. Drugs affected by the new acetaminophen limits include Vicodin (acetaminophen and hydrocodone), Percocet (acetaminophen and oxycodone), and Tylenol with Codeine (acetaminophen and codeine).

The recall affects about 898,000 1/2 fl. oz. bottles of Rugby Children’s Pain & Fever Concentrated Drops (Acetaminophen Drops). The recalled bottles have UPC code 305361936723 on a bar code on the bottom of the box and lot numbers 09002, 09131, 09215, 09379, 09394, 10154, 10272, 10273,10366,10368, 10406, 10433, 10487 and 11058. The lot numbers are stamped into the bottom of the box and printed above the label on the bottle itself in black.

The recalled children’s drops were sold at drug stores and grocery stores nationwide from January 2009 through June 2011 for about $4.

The CPSC recommends that consumers make sure the child-resistant cap is in use and that it is stored out of the reach of children. A replacement dropper can be obtained by calling Altaire Pharmaceuticals at (800)258-2471.