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.
What this means for you
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
- Hazard
- sterility-assurance
- microbial-contamination
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.
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