Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
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 for a parenteral (injectable) product with unassured sterility. While no illnesses have been reported in the source material, this constitutes a risk-of-harm product where the theoretical risk of bacterial or fungal contamination in an injectable medication carries significant potential for patient harm, meeting High severity criteria.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 18,840 pre-filled syringes of Succinylcholine Chloride Injection, USP (20 mg/mL), nationwide due to lack of assurance of sterility.
The recalled syringes are from lot SU2014A with expiration date July 2, 2022. Succinylcholine Chloride is a prescription injectable medication used during anesthesia in surgical and medical settings.
Healthcare facilities and practitioners should immediately discontinue use of affected syringes. Those with questions should contact Nephron Sterile Compounding Center LLC at 4500 12th Street Extension, West Columbia, SC 29172. Patients who received doses from this lot should inform their healthcare provider.
The recalled product
- Product
- Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- sterility-failure
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: SU2014A
- Exp. 7/2/2022
Distribution
Distributed nationwide across the United States.
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