IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmac
Summary
The FDA issued a Class I for IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL by Teva Pharmaceuticals USA Inc. Reason: Presence of Particulate Matter: Product was found to contain silica and iron oxide.
Details
Source
Drug Recall
External ID
D-0765-2022
Action Date
2022-04-20
Status
Terminated
Category
drug
Product Description
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
Lot/Code Info: Lot #: 31329657B, Exp. Date 08/2023
Quantity Affected: 1565 vials
Reason for Recall
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-29
Company
Parsippany, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 38 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0765-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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