CLASS II Drug recall · Reported 23 Oct 2019 · FDA Enforcement Report
Ascorbic Acid Sterile Injection Solution, 500 mg/mL vial recalled
Atlas Pharmaceuticals is recalling Ascorbic Acid Sterile Injection Solution, 500 mg/mL vial, Non-Corn Source, distributed in Arizona, Colorado. The recall was initiated on 28 Aug 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0144-2020
- FDA event ID
- 83710
- Recalling firm
- Atlas Pharmaceuticals, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2019
- FDA classified
- 15 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Aug 2019 | Recall initiated by company | |
| 15 Oct 2019 | Classified by FDA | +48 days |
| 23 Oct 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Healthcare facilities/clinics in AZ and CO
Questions about this recall
Is Ascorbic Acid Sterile Injection Solution, 500 mg/mL vial, Non-Corn Source recalled?
Yes. Atlas Pharmaceuticals recalled Ascorbic Acid Sterile Injection Solution, 500 mg/mL vial, Non-Corn Source on 28 Aug 2019. The recall is Class II and its status is Terminated. Recall number D-0144-2020.
Why was it recalled?
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Which lots are affected?
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
Where was it sold?
Healthcare facilities/clinics in AZ and CO
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.