Drug Enforcement D-1071-2023

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

Status

Terminated

Classification

Class II

Report Date

August 9, 2023

Termination Date

March 21, 2025

Product Information

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
Product quantity
2,994 syringes
Reason for recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Central Admixture Pharmacy Services Inc
Address
7935 Dunbrook Rd Ste C, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1071-2023
Event ID
92752
Recall initiation date
July 17, 2023
Center classification date
August 3, 2023
Code info
Lot: 17-274122, 17-274147, 17-274155, 17-274158, 17-274162, Exp. 9/13/2023
More code info
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