Home / Recalls / Apotex Corp. / D-0093-2023

D-0093-2023 Class III Terminated

Recalled by Apotex Corp. — Weston, FL

Recall Details

Product Type: Drugs
Report Date: January 4, 2023
Initiation Date: December 21, 2022
Termination Date: October 8, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,027 bottles

Product Description

Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4

Reason for Recall

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

Distribution Pattern

USA Nationwide

Code Information

Lot# TA4844, Exp 03/2023

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