Succinylcholine chloride injection recalled for lack of sterility assurance
SCA Pharmaceuticals recalls Succinylcholine Chloride 200 mg/10mL injectable due to lack of assured sterility. The recall affects 8,755 syringes distributed nationwide.
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 of an injectable pharmaceutical with lack of assured sterility, presenting a contamination risk. No illnesses or injuries have been reported, placing this within the high-risk category per FDA guidance.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling Succinylcholine Chloride 200 mg/10mL Injection (20 mg/mL concentration) due to lack of assured sterility. The affected product has NDC 70004-0908-12 and was distributed nationwide.
The recall involves 8,755 syringes across the following lot numbers with stated expiration dates: 1223049047 (11/29/23), 1223049221 (12/06/23), 1223049343 (12/12/23), 1223049423 (12/14/23), 1223049451 (12/14/23), 1223049452 (12/14/23), and 1223049482 (12/14/23).
Healthcare providers and pharmacies that have received this product should stop using it and contact SCA Pharmaceuticals for instructions on return or disposal. Patients who have received treatment with affected lots should consult their healthcare provider for guidance.
The recalled product
- Product
- SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 8,755
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 (7)
- Lot #: 1223049047 Exp 11/29/23
- 1223049221 Exp 12/06/23
- 1223049343 Exp 12/12/23
- 1223049423 Exp 12/14/23
- 1223049451 Exp 12/14/23
- 1223049452 Exp 12/14/23
- 1223049482 Exp 12/14/23
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.
See all 32 products in this recall →Related recalls
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