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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Pfizer Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot #s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1278-2019
Related Recalls
Lack of Assurance of Sterility.
Lack of Assurance of Sterility.
Subpotent drug