Bromfenac Ophthalmic Solution 0.09% recall: Sterility Concern
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…
Why was Bromfenac Ophthalmic Solution 0.09% recalled?
Lack of Assurance of Sterility: Failed preservative effectiveness test
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Mayne Pharma Usa
- Quantity
- a) 52034 bottles and b) 22074 bottles
- Distribution
- Nationwide
- Recall date
- January 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)