Ketamine syringes recalled for lack of sterility assurance
CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.
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 injectable drug recall with no reported illnesses or injuries. The manufacturing control concern regarding sterility assurance on an injectable product poses a serious infection risk, meeting the criteria for High severity per the rubric.
Plain-English summary
Central Admixture Pharmacy Services Inc. (CAPS) is recalling 4,775 5mL ketamine syringes containing 50 mg/5mL (10mg/mL) concentration distributed nationwide. The affected lots with expiration dates between October 2-8, 2023 are: 17-275224, 17-275225, 17-275233, 17-275235, 17-275253, 17-275259, 17-275263, 17-275267, 17-275340, 17-275512, 17-275633, and 17-275657.
The recall was initiated because the manufacturer could not assure the product met sterility standards during manufacturing and testing. Ketamine syringes that lack sterile assurance could potentially be contaminated with microorganisms that pose a serious infection risk if injected.
Healthcare facilities and pharmacies that received these products should quarantine affected syringes immediately and not dispense or use them. Facilities should contact CAPS or their supplier to arrange return of unused product. No illnesses or injuries related to this recall have been reported to date.
The recalled product
- Product
- ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Compounded
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 (15)
- Lot: 17-275224
- 17-275225
- 17-275233
- 17-275235
- 17-275253
- 17-275259
- 17-275263
- 17-275267 Exp. 10/2/2023
- 17-275340
- Exp. 10/3/2023
- 17-275512
- Exp. 10/5/2023
- 17-275633
- 17-275657
- Exp. 10/8/2023.
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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