Class III
Terminated
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.
- Company
- Pfizer Inc.
- Recall Initiated
- April 29, 2019
- Posted
- May 22, 2019
- Recall Number
- D-1278-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 100277 tablets
- Firm Location
- New York, NY, United States
Reason for Recall
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.
Distribution
Nationwide in the USA
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.
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