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Recall Observatory FDA recall evidence

Drug product

Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.

D-0144-2020

August 28, 2019

Class II

Product summary

Firm
Atlas Pharmaceuticals, LLC
Event
Event 83710
Status
Terminated
Classification
Class II
Quantity
1646 vials
Official record key
drug-enforcement:D-0144-2020

Official wording

Reason: Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.

Code information: Lot #: S-60162, BUD 10/12/2019; S-60176, BUD 11/2/2019; S-60187, BUD 11/11/2019; S-60189, BUD 11/16/2019; S-60190, BUD 11/16/2019; S-60222, BUD 01/20/2020

Distribution pattern: Healthcare facilities/clinics in AZ and CO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.