Why it was recalled
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Product description
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
Lot numbers, UPCs & expiration codes
a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
Where it was sold
U.S. 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-0487-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 12, 2015
- FDA report date
- Apr 22, 2015
- Quantity
- 33,795 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0487-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 70720
- Address
- 150 Signet Drive
- Code information
- a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
- Report date
- Apr 22, 2015
- Product type
- Drugs
- Recall number
- D-0487-2015
- Classification
- Class III
- Recalling firm
- Apotex Inc.
- Product quantity
- 33,795 Bottles
- Termination date
- Dec 30, 2016
- Reason for recall
- CGMP Deviations: Product excipient was not re-tested at the appropriate date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Feb 12, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2015