Eye Drop Recall: Brimonidine Tartrate Due to Cracked Bottle Caps
Apotex Corp. is recalling Brimonidine Tartrate eye drops (67,056 bottles nationwide) because cracks in bottle caps may compromise sterility and expose patients to contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical (cracks may compromise sterility), not confirmed harm. Per the rubric, recalls with theoretical hazards and no reported injuries score at most 3.
Plain-English summary
Apotex Corp. is recalling Brimonidine Tartrate Ophthalmic Solution 0.15%, a prescription eye medication manufactured by Apotex Inc. in Toronto, Ontario and distributed for Apotex Corp. in Weston, Florida. The recall is due to lack of sterility assurance: cracks have developed in some bottle caps, which may compromise the sterility of the medication.
The recall affects 67,056 bottles of this ophthalmic solution distributed nationwide in the United States. The product is supplied in three dropper bottle sizes: 5 mL (NDC 60505-0564-1), 10 mL (NDC 60505-0564-2), and 15 mL (NDC 60505-0564-3).
Specific lot numbers and expiration dates for the affected bottles are listed in the FDA recall notice, which should be consulted to determine if your supply is affected.
The recalled product
- Product
- BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
- Brand
- BRIMONIDINE TARTRATE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic solution
- Affected units
- 67,056
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
UPCs (3)
- 360505056415
- 360505056422
- 360505056439
Distribution
Distributed nationwide across the United States.
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