🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: January 5, 2016 Mayne Pharma Usa Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mayne Pharma Usa
Reason for Recall:
Lack of Assurance of Sterility: Failed preservative effectiveness test
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0585-2016