Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutan
Summary
The FDA issued a Class II for Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Via by Sagent Pharmaceuticals Inc. Reason: Labeling: Not elsewhere classified.
Details
Source
Drug Recall
External ID
D-0435-2023
Action Date
2023-03-15
Status
Terminated
Category
drug
Product Description
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
Lot/Code Info: Lot#: WP201, Exp 2/2024
Quantity Affected: 28,875 vials
Reason for Recall
Labeling: Not elsewhere classified
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-28
Company
Schaumburg, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Sagent Pharmaceuticals Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Sagent Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sagent Pharmaceuticals Inc have FDA actions?
Sagent Pharmaceuticals Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0435-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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