Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles
Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.
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. The hazard involves potential contamination due to lack of sterilization process validation. This represents a risk-of-harm for injectable medication, meeting the High severity criterion in the established rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. (CAPS Inc) is recalling 26,208 syringes of succinylcholine 200 mg/10 mL. The product was distributed nationwide in the United States, repackaged by CAPS Inc at 2200 South 43rd Avenue, Phoenix, AZ. The recall affects multiple lot numbers with expiration dates from July through August 2023 (NDC 72196-6011-2).
The reason for the recall is a lack of assurance of sterility. The manufacturer does not have adequate validation data for the decontamination cycles used in manufacturing. This means there is no sufficient proof that the sterilization process has adequately removed microorganisms from the syringes before distribution.
This is a Class II recall. Healthcare facilities and providers who have received this product should verify their inventory against the affected lot numbers and expiration dates listed in this recall notice.
The recalled product
- Product
- succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Affected units
- 26,208
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 (20)
- Lot: 36-238812
- 36-238813
- 36-238814
- 36-238815
- 36-238816
- 36-238819
- Exp. 7/10/2023
- 36-239281
- 36-239282
- 36-239284
- Exp. 7/11/2023
- 36-239459
- 36-239460
- 36-239628
- 36-239629
- Exp. 7/12/2023
- 36-239879
- 36-239880
- 36-239881
- Exp. 7/13/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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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