Recalls / Class III
Class IIID-0093-2023
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
- Affected lot / code info
- Lot# TA4844, Exp 03/2023
Why it was recalled
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.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 22,027 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-12-21
- FDA classified
- 2022-12-28
- Posted by FDA
- 2023-01-04
- Terminated
- 2025-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0093-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.