Relpax Recalled Due to Bacterial Contamination

Replax bacterial contamination

UNITED STATES – According to an online news article published by www.ibtimes.com, Pfizer, Inc. has recalled 2 lots of its migraine drug “Relpax” with concerns that these 2 lots may have potential bacterial contamination.

Pfizer, Inc., the manufacturer of Relpax, a medication used for the acute treatment of migraine with or without aura in adults, recently issued a voluntary recall of 2 lots of the drug after learning that the lots may be contaminated with harmful bacteria.

The specific bacteria at issue “come from the genera Pseudomonas and Burkholderia.”  According to the article, once the bacteria enter the bloodstream, “they are capable of causing serious, life-threatening infections, or temporary gastrointestinal distress without infection.”

While Pfizer states that the risk of infection and harm are low for the general population, certain groups, such as those with compromised immune systems, cystic fibrosis, and chronic granulomatous disease, may be at greater risk of becoming ill if exposed to the harmful bacteria.

Pfizer has not received any adverse event reports regarding illnesses associated with the affected lots of Relpax.

Specific Recall Information for Relpax

The United States Food and Drug Administration (FDA) has issued a public health notification informing patients and the medical community about Pfizer’s voluntary recall of Relpax.  The notification provides the following recall information for the affected lots of Relpax.

• Drug Name and Dosage: Relpax (eletriptan hydrobromide) 40 mg tablets
• NDC Number: 0049-2340-45
• Lot Numbers: AR5407 (carton containing 1 blister card and 6 tablets) and CD4565 (carton containing 2 blister cards and 6 tablets)
• Expiration Date: February 2022
• Distribution Dates: June to July 2019

The affected lots of Relpax were distributed to wholesalers, retailers, hospitals, and healthcare providers throughout the United States and Puerto Rico.

Those with the affected lots are instructed to stop using the product immediately and quarantine the product.  Retailers, hospitals, and healthcare providers who have dispensed the affected lots to patients are instructed to notify the patients about the recall.

Patients are also encouraged to speak with their healthcare providers and/or pharmacies to determine whether the Relpax they are taking is subject to recall.