Home / Recalls / Apotex Corp. / D-0120-2024

D-0120-2024 Class II Ongoing

Recalled by Apotex Corp. — Weston, FL

FDA drug recall D-0120-2024 was initiated by Apotex Corp. on Nov 1, 2023 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine The recall status is ongoing. Affected quantity: 48,623.

Recall details

Product Type: Drugs
Report Date: Dec 6, 2023
Initiation Date: Nov 1, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48,623

Product description

Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 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

Distribution pattern

Nationwide

Code information

Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0120-2024
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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