Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Product description
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Lot numbers, UPCs & expiration codes
Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
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-0009-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 25, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0009-2016, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 72341
- Address
- 150 Signet Drive
- Code information
- Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0009-2016
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
- Termination date
- Jun 15, 2022
- Reason for recall
- Lack of Assurance of Sterility: Failed preservative effectiveness testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 25, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2015