FDAFDA · Food and drugs·Recall number D-0009-2016
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.
Published October 21, 2015 · Recall initiated: August 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Failed preservative effectiveness testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide
- Lot
- Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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