Drug recall D-0093-2023

Class III Terminated reported Jan 4, 2023

Product

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.

Lots and codes

Lot# TA4844, Exp 03/2023

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
22,027 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 21, 2022
Terminated
October 8, 2025