Succinylcholine Chloride Injectable Drug Recalled Nationwide for Manufacturing Facility Contamination Risk
Advanced Compounding Solutions is recalling 493 syringes of succinylcholine chloride injection due to potential contamination from manufacturing facility violations affecting product sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving potential sterility compromise of an injectable medication due to manufacturing facility violations. No illnesses or injuries have been reported; the hazard is theoretical but significant given the critical nature of sterile injectables.
Plain-English summary
Advanced Compounding Solutions, doing business as New England Life Care, Inc., is recalling succinylcholine chloride injection (200 mg/10 mL, supplied in 10 mL syringes) distributed nationwide. The recall affects 493 syringes from Lot # 20230524-23C29D with expiration date September 21, 2023 (NDC: 71546-083-10).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) violations discovered during production. Spaces adjacent to the production area were potentially compromised at the time of manufacturing. Succinylcholine chloride is a critical injectable medication used in anesthesia, and any compromise to sterility poses a direct risk to patient safety.
Healthcare facilities and pharmacies that received product from this lot should immediately stop use and isolate remaining stock. Healthcare providers and patients who believe they may have received affected product should contact Advanced Compounding Solutions or the FDA with questions. The FDA has classified this recall as Class II.
The recalled product
- Product
- SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
- Affected units
- 493
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 # 20230524-23C29D
- Exp 21SEP2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by New England Life Care, Inc. dba Advanced Compounding Solutions under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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