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.
Reported: April 22, 2015 Initiated: February 12, 2015 #D-0487-2015
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.
Reason for Recall
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 33,795 Bottles
- Distribution
- U.S. Nationwide.
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Apotex Inc.. Units affected: 33,795 Bottles.
Why was this product recalled? ▼
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 22, 2015. Severity: Low. Recall number: D-0487-2015.
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