FDAFDA · Food and drugs·Recall number D-0093-2023
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
Published January 4, 2023 · Recall initiated: December 21, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Corp.
- Distributor
- USA Nationwide
- Lot
- Lot# TA4844, Exp 03/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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