Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Reported: January 27, 2016 Initiated: January 5, 2016 #D-0585-2016
Product Description
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Reason for Recall
Lack of Assurance of Sterility: Failed preservative effectiveness test
Details
- Recalling Firm
- Mayne Pharma Usa
- Units Affected
- a) 52034 bottles and b) 22074 bottles
- Distribution
- Nationwide
- Location
- Greenville, NC
Frequently Asked Questions
What product was recalled? ▼
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. Recalled by Mayne Pharma Usa. Units affected: a) 52034 bottles and b) 22074 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Failed preservative effectiveness test
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 27, 2016. Severity: Moderate. Recall number: D-0585-2016.
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