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Recall Observatory FDA recall evidence

Drug product

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.

D-0009-2016

August 25, 2015

Class II

Product summary

Firm
Apotex Inc.
Event
Event 72341
Status
Terminated
Classification
Class II
Quantity
5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
Official record key
drug-enforcement:D-0009-2016

Official wording

Reason: Lack of Assurance of Sterility: Failed preservative effectiveness testing

Code information: Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility