Reported Oct 21, 2015 · Terminated
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC…
Apotex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Inc. · 150 Signet Drive · Toronto, N/A · N/A
Is this the product you have?
- 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 forApotex Corp., Weston, FL 33326
- Lot codes and dates
Lot #: a) MF0537Exp 07/2016b) MF8090MF0532Exp 07/2016
- Amount recalled
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing
This product could cause temporary or reversible health problems — stop using it.
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