Methohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
OneSource Specialty Pharma Limited is recalling one lot of Methohexital Sodium for Injection due to failed impurities and degradation specifications. The affected product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for failed impurities and degradation specifications with no reported illnesses or injuries. The source text does not indicate any adverse health events, making this a precautionary quality/specification recall, which typically falls into the Moderate category per the rubric.
Plain-English summary
OneSource Specialty Pharma Limited is recalling Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vials because the product failed impurities and degradation specifications. The recalled lot is #7000612A with an expiration date of 1/2028. Approximately 4,284 vials were distributed nationwide within the United States.
Methohexital Sodium is a prescription anesthetic drug administered by intramuscular, intravenous, or rectal injection. Products that do not meet established purity and stability standards may pose safety risks to patients.
Patients and healthcare providers who have this medication should not use it and should contact their healthcare provider or pharmacist for guidance. The recalling firm is OneSource Specialty Pharma Limited, Bengaluru, India. The product was manufactured for Avet Pharmaceuticals Inc., East Brunswick, New Jersey. The NDC number is 23155-893-31.
The recalled product
- Product
- METHOHEXITAL SODIUM (METHOHEXITAL SODIUM)
- Brand
- METHOHEXITAL SODIUM
- Manufacturer
- ONESOURCE SPECIALTY PHARMA LIMITED
- Category
- Drug — Injectable Anesthetic
- Affected units
- 4,284
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 7000612A
- Exp. Date 1/2028
UPCs (2)
- 0323155893311
- 0011100004492
Distribution
Distributed nationwide across the United States.
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