Reported Jan 4, 2023 · Terminated
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg…
Apotex Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253
Is this the product you have?
- Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only
- Mfg byApotex Inc. Toronto
- Ontario Canada M9L 1T9 Mfg for
Apotex Corp. WestonFL 33326NDC 60505-1005-4
- Lot codes and dates
Lot# TA4844Exp 03/2023
- Amount recalled
- 22,027 bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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