Why it was recalled
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Product description
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326
Lot numbers, UPCs & expiration codes
Lots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024
Where it was sold
Nationwide in the USA
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-0433-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 1, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 67,056 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0433-2023, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Completed
- Country
- United States
- Event ID
- 91803
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024
- Postal code
- 33326-3253
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0433-2023
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 67,056 bottles
- Reason for recall
- Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 1, 2023
- Initial firm notification
- Press Release
- Center classification date
- Mar 3, 2023