Recalls / Class III
Class IIID-1278-2019
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.
- Brand name
- Relpax
- Generic name
- Eletriptan Hydrobromide
- Active ingredient
- Eletriptan Hydrobromide
- Route
- Oral
- NDCs
- 0049-2330, 0049-2340
- FDA application
- NDA021016
- Affected lot / 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.
Why it was recalled
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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- ROERIG
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 100277 tablets
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-29
- FDA classified
- 2019-05-13
- Posted by FDA
- 2019-05-22
- Terminated
- 2021-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1278-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.