Food, drugs, devices › Amerisource Health Services LLC
Drug recall: Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals
Amerisource Health Services LLC (Columbus, OH) initiated this drug recall on 27 Jul 2022; FDA lists 1 product record under event 90677, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 28 Sep 2023. Initiation: voluntary: firm initiated. Amerisource Health Services LLC has 31 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Amerisource Health Services LLC, Columbus, OH.
Reason for recall
"Subpotent Drug"
Distribution
"Nationwide within the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1349-2022 | 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 | 4,160 vials | Class III | Terminated | 24 Aug 2022 |
Context
Other enforcement events for Amerisource Health Services LLC
All 31 events for Amerisource Health Services LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Sep 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.