The FDA said Thursday that Pfizer has issued a voluntary recall for 6- and 12-tablet packages of migraine medicine because of “microbiological contamination.”
According to an FDA news release, bacteria in the medicine could move from the gut to the bloodstream, potentially resulting in serious, life-threatening infections.
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Also, people who take the medicine could experience temporary gastrointestinal distress without serious infection.
The FDA said these risks are low in most people. However, patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease, may have the potential for serious adverse effects including life-threatening infections.
Pfizer said they have not received any customer complaints or reports of adverse events related to this issue.
The affected Relpax lots were distributed nationwide to wholesalers, retailers, hospitals, and healthcare providers in the United States and Puerto Rico from June 2019 to July 2019.
Below are the products affected by the recalled:
| Carton NDC | Lot Number | Expiration Date | Strength | Configuration/Count |
|---|---|---|---|---|
| 0049-2340-45 | AR5407 | 2022 FEB | 40 mg | Carton containing 6 tablets (1 blister card x 6 tablets) |
| 0049-2340-05 | CD4565 | 2022 FEB | 40 mg | Carton containing 12 tablets (2 blister cards x 6 tablets) |
Anyone with the medication should stop using it immediately and inform their healthcare professional.
For additional assistance, call 877-225-9750 Monday through Friday 8 a.m. to 5 p.m. ET.
