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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,

D-483-2013

April 22, 2013

Class II

Product summary

Firm
Nora Apothecary and Alternative Therapies, Inc.
Event
Event 65019
Status
Terminated
Classification
Class II
Quantity
14
Official record key
drug-enforcement:D-483-2013

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Code information: All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility