Elevated site urgencyFDA Class II

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0

Lack of Assurance of Sterility

Agency
FDA Drug
Recall date
Mar 5, 2026
Status
Ongoing
Company
Apotex Corp.

1. What product was recalled?

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

Quantity: 107,136 vials

Code or lot text: Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027

LOT
Exp Date 01/31/2027
LOT
Exp Date 09/30/2026 & VL1668
LOT
Lots VJ8599
NDC
60505-0589
NDC
60505-0589-1
NDC
60505-0589-2
NDC
60505-0589-3
RECALL-NUMBER
D-0407-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Lack of Assurance of Sterility

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.