GlaxoSmithKline Recalls Improperly Child-Proofed Products

GlaxoSmithKline has voluntarily recalled four lots of Panadol Advance 100-count bottles in Puerto Rico. The recall for the pain relief medication was issued due to a lack of appropriate child-resistant packaging to protect against access by young children. Panadol Advance contains acetaminophen, which is required to be noted clearly on the label and given special packaging to avoid acetaminophen overdose or poisoning.

Panadol Advance bottles should always have child-resistant packaging or be labeled as a product “for households without young children,” yet the current packaging is not up to code.

The lots included in the recall are 14241, 14002, 13881, and 13801, with expiration dates of 02/2015, 10/2014, 09/2014, and 09/2014 respectively. The lot and expiration date of a particular bottle can be identified by looking on the left side of the label near the bar code. These lots could be bought exclusively at drug stores and retail establishments in Puerto Rico, so any products purchased within the mainland of the United States should not be affected.

The four lots include all of the current supply of this product in Puerto Rico. This means that Panadol Advance will be out of stock and off shelves until new shipments can be sent. “GSK regrets the inconvenience this issue may cause. We are working diligently to bring back to shelves the products our consumers trust and love,” said the company in a statement on its website.

Thus far, no injuries or related incidents have been reported, and the medication itself is still safe to use as directed. However, it is important to be vigilant against risk of unintentional ingestion and overdose.

Acetaminophen Poisoning Risks

The Food and Drug Administration (FDA) has given special attention to the risks of acetaminophen, which is easily found in more than 600 over-the-counter products. While an effective pain reliever in proper doses, taking too much of the medication can do serious health damage.

Acetaminophen toxicity has been a problem in the United States in recent years. Up to 80,000 people in the United States overdose on acetaminophen every year, according to the FDA. About 500 of these cases are fatal. The agency has pushed pharmaceutical companies to do more to warn consumers to be careful when taking these over-the-counter painkillers.

One important step to limit acetaminophen poisoning has been the requirement for child-safe packaging on all products containing the drug under the Poison Prevention Packaging Act enforced by the Consumer Product Safety Commission (CPSC).

Since the packaging of Panadol Advance does not meet the requirements of this act, the CPSC would have required a recall had the company not voluntarily removed the products. “Consumers should immediately place the product out of a child’s sight and reach, and contact GSK for a refund,” the CPSC said in a statement.

Customers can contact GSK toll-free at (888) 912-8455 from 9 a.m. to 5 p.m. ET Monday through Friday at their dedicated recall line in order to ask questions or find out how to get a refund.

Source:

http://www.fiercepharmamanufacturing.com/story/gsk-recalls-acetaminophen-products-were-not-child-proofed/2014-07-17