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Recall Observatory FDA recall evidence

Drug product

Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

D-0870-2016

January 20, 2015

Class I

Product summary

Firm
Pacifico National, Inc. dba AmEx Pharmacy
Event
Event 73560
Status
Terminated
Classification
Class I
Quantity
836 syringes
Official record key
drug-enforcement:D-0870-2016

Official wording

Reason: Non-Sterility: Product tested positive for bacterial contamination.

Code information: Lot #: 150116B, Exp. 04/16/2015; 150119R, Exp. 04/19/2015; 150316H, Exp. 06/14/2015

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination