ONESOURCE SPECIALTY PHARMA LIMITED — Class II: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by
OneSource Specialty Pharma Limited has initiated a Class II recall of Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vials due to failure to meet impurities and degradation specifications.
This recall affects the manufacturer (OneSource Specialty Pharma Limited), the distributor (Avet Pharmaceuticals Inc.), and healthcare facilities or departments utilizing methohexital sodium for injection (NDC 23155-893-31).
A failure in impurity or degradation specifications suggests a potential loss of product stability or possible manufacturing process variability. While it is a Class II recall, indicating the probability of serious adverse health consequences is remote, regulatory teams should assess the root cause to determine if the issue is batch-specific or indicative of broader systemic gaps in stability monitoring or quality control.
QA and procurement teams should verify specific batch numbers and expiration dates against the NDC 23155-893-31 inventory and isolate any units remaining in the distribution chain. Manufacturing teams may need to review impurity profile trends for methohexital sodium production processes.
Class II. Reason: Failed Impurities/Degradation Specifications. Product: 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. Firm: ONESOURCE SPECIALTY PHARMA LIMITED (Bengaluru N/A India). Status: Ongoing.
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