Injectable Succinylcholine Syringes Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc is recalling 3,590 succinylcholine 200 mg/10 mL syringes distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.
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 lack of assurance of sterility in an injectable drug product. No illnesses or injuries have been reported in the source. The hazard is theoretical rather than confirmed contamination, but sterility assurance is critical for injectable pharmaceuticals.
Plain-English summary
Central Admixture Pharmacy Services Inc has recalled succinylcholine 200 mg/10 mL injectable syringes (20 mg/mL) distributed nationwide. A total of 3,590 syringes are affected by this FDA Class II recall.
The recall is due to lack of assurance of sterility. Affected lot numbers expire between October 3 and October 18, 2023.
No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Hazard
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 (12)
- Lot:17-275343
- Exp. 10/3/2023
- 17-275472
- 17-275489
- Exp.10/4/2023
- 17-275876
- Exp. 10/11/2023
- 17-275976
- 17-275985
- Exp. 10/15/2023
- 17-276204
- Exp. 10/18/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by Central Admixture Pharmacy Services Inc 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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