Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

FDA recall notice · announced December 29, 2021 · The Harvard Drug Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide USA
Lot/code information: Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022
Quantity: 2,239 bottles
Status: Terminated
Products in this recall event:
- Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40 (D-0289-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.