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Recall Observatory FDA recall evidence

Drug product

methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401

D-0888-2017

June 01, 2017

Class II

Product summary

Firm
MedPark Pharmacy, LLC
Event
Event 77428
Status
Terminated
Classification
Class II
Quantity
1 (5mL) vial
Official record key
drug-enforcement:D-0888-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 20170323-01, Exp.09/18/2017

Distribution pattern: Distributed to patient in Maryland

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility