RELPAX tablets recalled over sterility concerns

Recall date

August 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pfizer Inc. recalls RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12…

Recall number

D-1845-2019

FDA classification

Class II

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.