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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

BluePoint Laboratories Azacitidine for Injection Recalled for Subpotency

Agency Publication Date: August 17, 2022
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Summary

Amerisource Health Services LLC is recalling 4,160 vials of Azacitidine for Injection (100 mg), a prescription medication sold under the BluePoint Laboratories brand. The drug is being recalled because testing determined it was subpotent, meaning it contains less than the required amount of the active ingredient. No incidents or injuries related to this recall have been reported.

Risk

Using a subpotent medication may result in a patient receiving a lower dose than intended, which could reduce the effectiveness of the treatment.

What You Should Do

  1. This recall affects BluePoint Laboratories Azacitidine for Injection, 100 mg Lyophilized Powder Single-Dose Vials (NDC 68001-0313-56) with lot number FE22001A and an expiration date of 01/2024.
  2. Stop using the recalled product immediately.
  3. Contact Amerisource Health Services LLC or your pharmaceutical distributor to arrange for the return of the affected vials.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Azacitidine for Injection (100 mg)by BluePoint Laboratories
Variants: Lyophilized Powder, Single-Dose Vial, Rx Only
Lot Numbers:
FE22001A (Exp 01/2024)
NDC:
68001-0313-56

Manufactured by Intas Pharmaceuticals Limited in India for BluePoint Laboratories. Recall # D-1349-2022.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90677
Status: Resolved
Manufacturer: Amerisource Health Services LLC
Sold By: BluePoint Laboratories
Manufactured In: India, United States
Units Affected: 4,160 vials
Distributed To: Nationwide

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.