Ketamine Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.
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: This is an FDA Class II recall of a high-risk sterile injectable drug where the manufacturing process lacks validated sanitization procedures. No illnesses, injuries, or actual contamination have been reported. As a risk-of-harm product where injury has not yet been reported, this qualifies as High severity per the rubric.
Plain-English summary
Ketamine injection in 0.9% sodium chloride (50 mg/5mL) manufactured by Central Admixture Pharmacy Services Inc is being recalled due to lack of assurance of sterility. This resulted from insufficient validation data for sanitization cycles used in product manufacture.
The recall affects 2,994 syringes distributed nationwide. The affected lot numbers are 17-274122, 17-274147, 17-274155, 17-274158, and 17-274162, with an expiration date of September 13, 2023.
Healthcare providers and facilities should verify whether they have received product from the recalled lots. Those with affected inventory should contact the manufacturer for information regarding appropriate handling of the recalled product.
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
- Affected units
- 2,994
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 (6)
- Lot: 17-274122
- 17-274147
- 17-274155
- 17-274158
- 17-274162
- Exp. 9/13/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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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