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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

D-0283-2022

December 03, 2021

Class II

Product summary

Firm
Valgene Incorporated dba Cape Drugs
Event
Event 89209
Status
Terminated
Classification
Class II
Quantity
27 vials
Official record key
drug-enforcement:D-0283-2022

Official wording

Reason: Lack of Processing Controls

Code information: Lot #: 188008, BUD 03/19/2022

Distribution pattern: Maryland Only

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls