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Recall Observatory FDA recall evidence

Drug product

BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.

D-1161-2017

August 15, 2017

Class II

Product summary

Firm
Bella Pharmaceuticals, Inc.
Event
Event 77959
Status
Terminated
Classification
Class II
Quantity
200 syringes
Official record key
drug-enforcement:D-1161-2017

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 08152017, Exp. 11/15/17

Distribution pattern: Nationwide within USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility