Drug product
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
D-0585-2016
Product summary
- Firm
- Mayne Pharma Usa
- Event
- Event 73072
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 52034 bottles and b) 22074 bottles
- Official record key
drug-enforcement:D-0585-2016
Official wording
Reason: Lack of Assurance of Sterility: Failed preservative effectiveness test
Code information: a) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527, Exp. Date: 06-2016; 0378-7110-35 AC6330, Exp. Date: 05-2016; 0378-7110-35 AC2330, Exp. Date: 04-2016 and b) Lot numbers: 0378-7109-35 AD4515, Exp. Date: 04-2016 and 0378-7109-35 AC2328, Exp. Date: 01-2016.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility