Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufa
Summary
The FDA issued a Class III for Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multipl by SOMERSET THERAPEUTICS LLC. Reason: Subpotent product:out of specification assay results observed during long term stability testing..
Details
Source
Drug Recall
External ID
D-0238-2026
Action Date
2025-12-24
Status
Ongoing
Category
drug
Product Description
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Lot/Code Info: Lot#: A250043, EXP Date 06/30/2026
Quantity Affected: 71,310 10mL vials
Reason for Recall
Subpotent product:out of specification assay results observed during long term stability testing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-26
Company
Somerset, 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 91 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SOMERSET THERAPEUTICS LLC has 6 FDA actions in our database, including 6 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 (SOMERSET THERAPEUTICS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SOMERSET THERAPEUTICS LLC have FDA actions?
SOMERSET THERAPEUTICS LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0238-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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