ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 D...

FDA Recall #D-1071-2023 — Class II — July 17, 2023

Recall #D-1071-2023 Date: July 17, 2023 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Recalling Firm

Central Admixture Pharmacy Services Inc — San Diego, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,994 syringes

Distribution

Nationwide in the USA

Code Information

Lot: 17-274122, 17-274147, 17-274155, 17-274158, 17-274162, Exp. 9/13/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated