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
Reported: January 4, 2023 Initiated: December 21, 2022 #D-0093-2023
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.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 22,027 bottles
- Distribution
- USA Nationwide
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 22,027 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 4, 2023. Severity: Low. Recall number: D-0093-2023.
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