D-1278-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2019
- Initiation Date
- April 29, 2019
- Termination Date
- April 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100277 tablets
Product Description
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 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 Pattern
Nationwide in the USA
Code Information
Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.