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

D-0120-2024 Class II Ongoing

Recalled by Apotex Corp. — Weston, FL

Recall Details

Product Type
Drugs
Report Date
December 6, 2023
Initiation Date
November 1, 2023
Termination Date
N/A
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

Other recalls by Apotex Corp.

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  • D-0495-2025 Class II — Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: (May 28, 2025)
  • D-0457-2025 Class II — Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apote (May 28, 2025)
  • D-0496-2025 Class II — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx O (May 28, 2025)
  • D-0494-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured b (May 28, 2025)
  • D-0326-2024 Class II — Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fil (February 9, 2024)
  • D-0121-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 6 (November 1, 2023)
  • D-0122-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60 (November 1, 2023)
  • D-0119-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: (November 1, 2023)