Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceutical
Summary
The FDA issued a Class III for Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only by Amerisource Health Services LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-1349-2022
Action Date
2022-08-24
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: FE22001A, Exp. Date 01/2024
Quantity Affected: 4,160 vials
Reason for Recall
Subpotent Drug
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-27
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amerisource Health Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amerisource Health Services LLC have FDA actions?
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1349-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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