Drug 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
D-0093-2023
Product summary
- Firm
- Apotex Corp.
- Event
- Event 91353
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22,027 bottles
- Official record key
drug-enforcement:D-0093-2023
Official wording
Reason: 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.
Code information: Lot# TA4844, Exp 03/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification