Drug 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.
D-1845-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 83533
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 20,117 cartons; b) 2,502 cartons
- Official record key
drug-enforcement:D-1845-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Code information: Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Microbial contamination
Microbial Contamination