FDA recall D-0144-2020

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.

Distribution

Healthcare facilities/clinics in AZ and CO

Key facts

Status

Terminated

Initiation date

2019-08-28

Report date

2019-10-23

Termination date

2020-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0144-2020