FDA-Drug2023-01-04Class III
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
Apotex Corp.
Hazard
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.
Sold states
USA Nationwide
Affected count
22,027 bottles
Manufactured in
2400 N Commerce Pkwy Ste 400, Weston, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2023Don't want to check this manually?
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