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.

Class I - Dangerous

💊 Drugs Recalled: February 12, 2015 Apotex Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Apotex Inc.
Reason for Recall:: CGMP Deviations: Product excipient was not re-tested at the appropriate date.
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%, 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.