D-0009-2016 Class II Terminated
FDA drug recall D-0009-2016 was initiated by Apotex Inc. on Aug 25, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Failed preservative effectiveness testing The recall status is terminated (terminated Jun 15, 2022). Affected quantity: 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532).
Recall details
- Product Type
- Drugs
- Report Date
- Oct 21, 2015
- Initiation Date
- Aug 25, 2015
- Termination Date
- Jun 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
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.
Reason for recall
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Distribution pattern
Nationwide
Code information
Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0009-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026