Key Takeaway

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 by Mayne Pharma Usa was recalled on January 5, 2016. The hazard: Lack of Assurance of Sterility: Failed preservative effectiveness test

FDA Drug Class II Terminated

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: January 5, 2016 ~a) 52034 bottles and b) 22074 bottles units affected D-0585-2016

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

Hazard / Reason

Lack of Assurance of Sterility: Failed preservative effectiveness test

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Mayne Pharma Usa

Greenville, NC, United States

View all 1 recalls by Mayne Pharma Usa →

Distribution

Nationwide

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Frequently Asked Questions

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