D-0093-2023 Class III Terminated
FDA drug recall D-0093-2023 was initiated by Apotex Corp. on Dec 21, 2022 and is designated Class III. 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. The recall status is terminated (terminated Oct 8, 2025). Affected quantity: 22,027 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 4, 2023
- Initiation Date
- Dec 21, 2022
- Termination Date
- Oct 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0093-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026