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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

D-1147-2017

August 15, 2017

Class II

Product summary

Firm
Bella Pharmaceuticals, Inc.
Event
Event 77959
Status
Terminated
Classification
Class II
Quantity
30 vials
Official record key
drug-enforcement:D-1147-2017

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 070717MC, Exp. 1/7/18

Distribution pattern: Nationwide within USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility