Pfizer Recalls Relpax Tablets Due to Incorrect Strength Labeling
Pfizer is recalling Relpax 40 mg tablets because secondary packaging incorrectly lists the strength as 20 mg. The error is on one side of the carton.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which typically corresponds to a low risk of adverse health consequences. The hazard is a minor labeling error regarding the declared strength, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Pfizer Inc. is recalling Relpax (eletriptan HBr) 40 mg tablets due to a labeling error on the secondary packaging. The artwork on one side of the carton incorrectly indicates that each tablet contains eletriptan hydrobromide equivalent to 20 mg eletriptan, rather than the correct 40 mg strength.
The recall affects 10,027 tablets distributed nationwide in the USA. The affected lots include W38322, W98482, W64062, X27517, and AJ3674. The product is distributed by Roerig, Division of Pfizer Inc.
Consumers should check their Relpax packaging for the incorrect 20 mg strength indication on the carton. If the packaging matches the description, they should contact their healthcare provider or pharmacist for guidance on the next steps.
The recalled product
- 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.
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100,277
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #s: a) W38322
- Exp 10/2020
- W98482
- Exp 03/2021
- b) W64062
- Exp 01/2021
- X27517
- AJ3674
- Exp 11/2021.
Distribution
Distributed nationwide across the United States.
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