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.

FDA recall notice · announced October 23, 2019 · Atlas Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Healthcare facilities/clinics in AZ and CO
Lot/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
Quantity: 1646 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.