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-
Recalled September 4, 2019 · FDA recall D-1845-2019 · Pfizer
Hazard
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. · FDA Class II
Units
a) 20,117 cartons; b) 2,502 cartons
Sold at
Nationwide in the USA and Puerto Rico.
Description
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Product
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.
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →