FDA Drug recall D-1845-2019
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45
- FDA Drug
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45 by Pfizer, citing microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1845-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-14 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
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.
Reason
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Identifiers
| code_info | Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1845-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.