Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.
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 for a manufacturing control failure in an injectable medication with potential for serious harm from contamination. Classified as High per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Succinylcholine Chloride 100 mg/5mL Injection is being recalled due to lack of assurance of sterility. This means the manufacturer cannot verify that the product has been properly sterilized. The recall affects 5,079 syringes that were distributed nationwide.
The product is manufactured by SCA Pharmaceuticals, LLC (755 Rainbow Rd., Windsor, CT 06095) with NDC number 70004-0908-09. Two lot numbers are affected: #1223049085 (expiration 11/29/23) and #1223049364 (expiration 12/12/23).
The recalled product
- Product
- SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 5,079
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 #:1223049085 Exp 11/29/23
- 1223049364 Exp 12/12/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA Pharmaceuticals, LLC 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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