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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas

D-0168-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
24500 milliliters
Official record key
drug-enforcement:D-0168-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: a) 04242018:27 Discard by: 9/15/2018; 04302018:55 Discard by: 10/27/2018; b) 03192018:33 Discard by: 9/15/2018; 05222018:28 Discard by: 11/18/2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility