Azacitidine for Injection Recalled Nationwide for Subpotent Dosage
Amerisource Health Services is recalling 4,160 vials of Azacitidine for Injection nationwide due to subpotency. The affected vials may contain less than the labeled 100 mg of active ingredient.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses, injuries, or safety hazards. The issue is subpotency—underpowered medication affecting efficacy rather than safety. The recall is voluntary and precautionary. Class III recalls are typically scored at low to moderate levels.
Plain-English summary
Amerisource Health Services LLC is recalling 4,160 vials of Azacitidine for Injection, 100 mg Lyophilized Powder, in single-dose vials. The medication was manufactured by Intas Pharmaceuticals Limited, based in Ahmedabad, India, for BluePoint Laboratories. The affected lot is FE22001A with an expiration date of January 2024.
The recall was initiated because the vials were found to be subpotent, meaning they contain less active ingredient than the labeled 100 mg amount. This lot was distributed nationwide throughout the United States.
Patients who received this medication should contact their healthcare provider for guidance. Healthcare professionals should quarantine and return any remaining vials from lot FE22001A to the recalling firm. The firm initiated this voluntary recall on July 27, 2022, and the recall was terminated on September 28, 2023.
The recalled product
- Product
- Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- Affected units
- 4,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: FE22001A
- Exp. Date 01/2024
Distribution
Distributed nationwide across the United States.
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