Reported May 22, 2019 · 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…
Pfizer Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 E 42nd St · New York, NY · 10017-5703
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: a) W38322Exp 10/2020W98482Exp 03/2021b) W64062Exp 01/2021X27517Exp 03/2021AJ3674Exp 11/2021
- Amount recalled
- 100277 tablets
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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