Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.

FDA recall notice · announced October 21, 2015 · Apotex

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.

Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing

Notes

Distribution: Nationwide
Lot/code information: Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
Quantity: 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Status: Terminated
Products in this recall event:
- Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326. (D-0009-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.