Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma
Summary
The FDA issued a Class II for Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manuf by ONESOURCE SPECIALTY PHARMA LIMITED. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0662-2026
Action Date
2026-07-15
Status
Ongoing
Category
drug
Product Description
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Lot/Code Info: Lot #: 7000612A, Exp. Date 1/2028
Quantity Affected: 4284 vials
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-07
Company
Bengaluru, N/A
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 44 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
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 (ONESOURCE SPECIALTY PHARMA LIMITED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ONESOURCE SPECIALTY PHARMA LIMITED have FDA actions?
This is the only FDA action we have on record for ONESOURCE SPECIALTY PHARMA LIMITED in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0662-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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