Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)10...
FDA Recall #D-0121-2024 — Class II — November 1, 2023
Product Description
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, 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
25,776
Distribution
Nationwide
Code Information
Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated