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Recall Observatory FDA recall evidence

Drug product

Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

D-1075-2015

March 17, 2015

Class II

Product summary

Firm
Fallon Wellness Pharmacy, L.L.C.
Event
Event 70807
Status
Terminated
Classification
Class II
Quantity
70 vials
Official record key
drug-enforcement:D-1075-2015

Official wording

Reason: Lack of assurance of sterility

Code information: Lot#: a) 02092015@59, Exp 4/10/15; b) 02122015@49, Exp 4/13/15; c) 02132015@44, Exp 4/14/15; d) 02192015@34, Exp 4/20/15

Distribution pattern: New York

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility