D-0487-2015 Class III Terminated
FDA drug recall D-0487-2015 was initiated by Apotex Inc. on Feb 12, 2015 and is designated Class III. Reason for recall: CGMP Deviations: Product excipient was not re-tested at the appropriate date. The recall status is terminated (terminated Dec 30, 2016). Affected quantity: 33,795 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 22, 2015
- Initiation Date
- Feb 12, 2015
- Termination Date
- Dec 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,795 Bottles
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.
Distribution pattern
U.S. Nationwide.
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0487-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026