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.
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
Lot numbers, UPCs & expiration codes
Lot# TA4844, Exp 03/2023
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0093-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 21, 2022
- FDA report date
- Jan 4, 2023
- Quantity
- 22,027 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0093-2023, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 91353
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot# TA4844, Exp 03/2023
- Postal code
- 33326-3253
- Report date
- Jan 4, 2023
- Product type
- Drugs
- Recall number
- D-0093-2023
- Classification
- Class III
- Recalling firm
- Apotex Corp.
- Product quantity
- 22,027 bottles
- Termination date
- Oct 8, 2025
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Dec 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2022