FDA Drug recall D-1278-2019
Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05
- FDA Drug
- Class III
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class III recall of Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05 by Pfizer, citing labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equiva….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1278-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-29 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
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.
Reason
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Identifiers
| code_info | Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021. |
|---|
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-1278-2019%22
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