Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufa...
FDA Recall #D-0122-2024 — Class II — November 1, 2023
Product Description
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 for Recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,074
Distribution
Nationwide
Code Information
Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated