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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Atlas Pharmaceuticals, LLC: Ascorbic Acid Injection Recalled Due to Incorrect "Non-Corn Source" Label

Agency Publication Date: October 15, 2019
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Summary

Atlas Pharmaceuticals, LLC is recalling 1,646 vials of its Ascorbic Acid (Vitamin C) Sterile Injection Solution, 500 mg/mL, because the product is labeled as being from a "Non-Corn Source" when it actually contains ingredients derived from corn. This recall affects 50 mL vials distributed to healthcare facilities and clinics in Arizona and Colorado between August 2019 and early 2020. Patients with severe corn allergies who receive this injection could experience a serious allergic reaction. If you have received this injection, you should contact your healthcare provider or pharmacist immediately, especially if you have a known corn allergy.

Risk

The product is mislabeled as being free of corn, but it actually contains corn-sourced ingredients. This poses a significant risk of severe allergic reactions or anaphylaxis for patients with corn hypersensitivity who are administered the injection.

What You Should Do

  1. Check your medical records or injection vials for Ascorbic Acid Sterile Injection Solution (500 mg/mL, 50 mL vial) with NDC 71591-500-50.
  2. Specifically look for the following lot numbers and Beyond Use Dates (BUD) on the label: 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), and S-60222 (BUD 01/20/2020).
  3. If you have any of these affected lots in your possession, do not use the product and set it aside in a secure location.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and report any concerns or adverse reactions.
  5. Return any unused vials to the pharmacy or healthcare facility where they were obtained for a refund.
  6. Contact Atlas Pharmaceuticals, LLC at their Phoenix office (711 E Carefree Hwy Ste 107, Phoenix, AZ 85085) for further instructions on returning the product.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return for refund and pharmacist consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ascorbic Acid Sterile Injection Solution (500 mg/mL, 50 mL vial)
Model:
NDC 71591-500-50
Lot Numbers:
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)
Date Ranges: BUD 10/12/2019, BUD 11/2/2019, BUD 11/11/2019, BUD 11/16/2019, BUD 01/20/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83710
Status: Resolved
Manufacturer: Atlas Pharmaceuticals, LLC
Sold By: Healthcare facilities; Clinics
Manufactured In: United States
Units Affected: 1646 vials
Distributed To: Arizona, Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.