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Pfizer issues medication recall for two lots of Relpax® 40 mg tablets

by
OWCA
| Aug 30, 2019

On August 15, 2019, the U.S. Food and Drug Administration (FDA) announced that Pfizer Inc. issued a voluntary recall for two lots of Relpax® (eletriptan) 40 mg tablets to the patient level. This recall was issued due to the potential presence of microbiological contamination of non-sterile products.

Relpax, also known as a triptan, is indicated for the acute treatment of migraine headaches, with or without aura. Triptans should be taken on an as needed basis at the onset of a migraine headache. These medications are not meant to be taken on a daily basis to prevent headaches.

According to the FDA, consuming oral products contaminated with microorganisms places certain patients at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life-threatening infections. There is also risk of temporary gastrointestinal distress without serious infection. For the general population these risks are low. To date, Pfizer has not received any customer complaints or reports of adverse events related to this recall.

The affected lots, as listed below, of Relpax 40 mg tablets were distributed nationwide to retailers, wholesalers, hospitals and healthcare providers in the U.S. and Puerto Rico from June 2019 to July 2019.

National Drug Code Lot Number Expiration Date Package Description/Count
AR5407 0049-2340-45 FEB 2022 Carton containing 6 tablets (1 blister card x 6 tablets)
0049-2340-05 CD4565 FEB 2022 Carton containing 12 tablets (2 blister cards x 6 tablets)

Pfizer has already notified its direct customers in writing to arrange for the return of all recalled products. For more information related to this recall, please click here.

Source:
U.S. Food and Drug Administration. Recalls, Market Withdrawals, and Safety Alerts. Company Announcement. Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of RELPAX® (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products. August 15, 2019. Available at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-inc-issues-voluntary-nationwide-recall-2-lots-relpaxr-eletriptan-hydrobromide-40-mg-tablets.



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