FDA Recall Relpax
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Relpax with NDC 0049-2340 was initiated on 08-14-2019 as a Class II recall due to microbial contamination of non-sterile products: contamination with burkholderia and pseudomonas. The latest recall number for this product is D-1845-2019 and the recall is currently terminated as of 06-20-2023 .
Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
---|---|---|---|---|---|---|
D-1845-2019 | 08-14-2019 | 09-04-2019 | Class II | a) 20,117 cartons; b) 2,502 cartons | 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. | Terminated |
D-1278-2019 | 04-29-2019 | 05-22-2019 | Class III | 100277 tablets | Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.