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