US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 5, 2016 (11 years ago)

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Failed preservative effectiveness test

What 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

Recalling firm
Mayne Pharma Usa
NDC code
0378-7110-35
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0585-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Bromfenac recalls

See all