Class II
Terminated
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.
This recall has been terminated (originally issued September 4, 2019).
- Company
- Pfizer Inc.
- Recall Initiated
- August 14, 2019
- Posted
- September 4, 2019
- Recall Number
- D-1845-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 20,117 cartons; b) 2,502 cartons
- Firm Location
- New York, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
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