Reported Mar 15, 2023 · Completed
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as
Apotex Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5 |
| 2 | 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2 |
| 3 | 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 codes and dates
- Lots
a) TJ9848 Exp. 02/2024TJ9849 Exp. 02/2024TK0258 Exp. 04/2024TK5341 Exp. 04/2024b) TK0261 Exp. 04/2024c) TK0262 Exp. 04/2024
- Lots
- Amount recalled
- 67,056 bottles
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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