Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Product description
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
Lot numbers, UPCs & expiration codes
Lot #221211, Expiry: 09/30/2015
Where it was sold
U.S. Nationwide and Puerto Rico
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-1349-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 13,995 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch & Lomb, Inc.
Original FDA data
Every field from FDA enforcement report D-1349-2015, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 71896
- Address
- 8500 Hidden River Pkwy
- Code information
- Lot #221211, Expiry: 09/30/2015
- Postal code
- 33637-1014
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1349-2015
- Classification
- Class II
- Recalling firm
- Bausch & Lomb, Inc.
- Product quantity
- 13,995 Bottles
- Termination date
- Apr 7, 2017
- Reason for recall
- Lack of Assurance of Sterility: Failed preservative effectiveness testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
- Distribution pattern
- U.S. Nationwide and Puerto Rico
- Recall initiation date
- Aug 17, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 20, 2015