Home / Recalls / Apotex Corp. / D-0324-2021

D-0324-2021 Class II Ongoing

Recalled by Apotex Corp. — Weston, FL

Recall Details

Product Type
Drugs
Report Date
April 14, 2021
Initiation Date
March 31, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55620 bottles

Product Description

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

Reason for Recall

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: RX1662, RX1663, RX1664 Exp. 11/2022

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-0494-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured b (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-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-0119-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: (November 1, 2023)
  • D-0122-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60 (November 1, 2023)