Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint La
Summary
The FDA issued a Class III for Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romani by Teva Pharmaceuticals USA Inc. Reason: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification..
Details
Source
Drug Recall
External ID
D-1334-2022
Action Date
2022-08-17
Status
Terminated
Category
drug
Product Description
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Lot/Code Info: Lot: FE22001A, Exp 01/2024
Quantity Affected: 4162 cartons
Reason for Recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Distribution
Distributed in Ohio
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-22
Company
Parsippany, NJ
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 41 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 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 (Teva Pharmaceuticals USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA Inc have FDA actions?
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1334-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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