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.
Reported: October 21, 2015 Initiated: August 25, 2015 #D-0009-2016
Product Description
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
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
- Distribution
- Nationwide
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Apotex Inc.. Units affected: 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532).
Why was this product recalled? ▼
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Moderate. Recall number: D-0009-2016.
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