December 2022 FDA Recall Drug by Apotex Corp.
D-0093-2023 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Apotex Corp. on December 21, 2022 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0093-2023

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.
Initiated
12-21-2022
Reported
01-04-2023
Quantity
22,027 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91353
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-08-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# TA4844, Exp 03/2023