D-1845-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2019
- Initiation Date
- August 14, 2019
- Termination Date
- June 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 20,117 cartons; b) 2,502 cartons
Product Description
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 Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB