Recalls / Class II
Class IID-0433-2023
Product
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
- Brand name
- Brimonidine Tartrate
- Generic name
- Brimonidine Tartrate
- Active ingredient
- Brimonidine Tartrate
- Route
- Ophthalmic
- NDC
- 60505-0564
- FDA application
- ANDA078479
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 67,056 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-01
- FDA classified
- 2023-03-03
- Posted by FDA
- 2023-03-15
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0433-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.