Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.
What this means for you
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. No illnesses or injuries reported, and the hazard is theoretical rather than confirmed. This meets the criterion for High severity: risk-of-harm product without reported injury.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of assurance of sterility. The recalled product is succinylcholine chloride injection, USP, 100 mg/5 mL (20 mg/mL), preservative-free, supplied in 5 mL pre-filled syringes.
The recall affects lots SU2004A (expiration 5/18/2022) and SU2007A (expiration 6/2/2022), totaling 181,560 units that were distributed nationwide.
Sterility is a critical requirement for injectable medications. Because the manufacturer cannot assure the sterility of these units, they initiated this recall. No adverse events have been reported to the FDA.
Healthcare providers should immediately stop using affected lots and return all remaining product to Nephron Sterile Compounding Center LLC. Patients who received injections from this product should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- infection-risk
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 (4)
- Lots: SU2004A
- Exp. 5/18/2022
- SU2007A
- Exp. 6/2/2022
Distribution
Distributed nationwide across the United States.
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