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Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b)...

FDA Recall #D-0119-2024 — Class II — November 1, 2023

Recall #D-0119-2024 Date: November 1, 2023 Classification: Class II Status: Ongoing

Product Description

Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, 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

34,392

Distribution

Nationwide

Code Information

Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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