FDA recall D-1845-2019

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.

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2019-08-14

Report date

2019-09-04

Termination date

2023-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1845-2019