Why it was recalled
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Product description
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Lot numbers, UPCs & expiration codes
Lot #: V18E01, Exp. 05/2020
Where it was sold
Nationwide within the United States
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-0422-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2019
- FDA report date
- Feb 6, 2019
- Quantity
- 69840 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0422-2019, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81958
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: V18E01, Exp. 05/2020
- Postal code
- 08512-3605
- Report date
- Feb 6, 2019
- Product type
- Drugs
- Recall number
- D-0422-2019
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 69840 bottles
- Termination date
- Feb 22, 2021
- Reason for recall
- Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 24, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2019