D-0144-2020 Class II Terminated
FDA drug recall D-0144-2020 was initiated by Atlas Pharmaceuticals, LLC on Aug 28, 2019 and is designated Class II. Reason for recall: Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source. The recall status is terminated (terminated Jun 3, 2020). Affected quantity: 1646 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 23, 2019
- Initiation Date
- Aug 28, 2019
- Termination Date
- Jun 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1646 vials
Product description
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 pattern
Healthcare facilities/clinics in AZ and CO
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0144-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026