Reported Jan 27, 2016 · 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…
Mayne Pharma USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mayne Pharma Usa · 1240 Sugg Pkwy · Greenville, NC · 27834-9006
Is this the product you have?
- 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
- Lot codes and dates
- a) Lot numbers0378-7110-35 AD4819, Exp
- Date
08-20160378-7110-35 AC7894Exp
- Date
05-20160378-7110-35 AD2527Exp
- Date
06-20160378-7110-35 AC6330Exp
- Date
05-20160378-7110-35 AC2330Exp
- Date04-2016
- and b) Lot numbers0378-7109-35 AD4515, Exp
- Date04-2016 and 0378-7109-35 AC2328, Exp
- Date01-2016
- Amount recalled
- a) 52034 bottles and b) 22074 bottles
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness test
This product could cause temporary or reversible health problems — stop using it.
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