Class II Recall

Apotex Corp.

Product
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Reason
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Classification
Class II
Status
Ongoing
Lot
Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
Date
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