Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness test
Product 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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0585-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 5, 2016
- FDA report date
- Jan 27, 2016
- Quantity
- a) 52034 bottles and b) 22074 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mayne Pharma Usa
Original FDA data
Every field from FDA enforcement report D-0585-2016, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 73072
- Address
- 1240 Sugg Pkwy
- 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.
- Postal code
- 27834-9006
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0585-2016
- Classification
- Class II
- Recalling firm
- Mayne Pharma Usa
- Product quantity
- a) 52034 bottles and b) 22074 bottles
- Termination date
- Jan 13, 2017
- Reason for recall
- Lack of Assurance of Sterility: Failed preservative effectiveness test
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 5, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2016