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.
Reported: September 4, 2019 Initiated: August 14, 2019 #D-1845-2019
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- a) 20,117 cartons; b) 2,502 cartons
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pfizer Inc.. Units affected: a) 20,117 cartons; b) 2,502 cartons.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2019. Severity: Moderate. Recall number: D-1845-2019.
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