Drug Enforcement D-1059-2023

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
fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Product quantity
19,014 bags
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-1059-2023
Event ID
92752
Recall initiation date
July 17, 2023
Center classification date
August 3, 2023
Code info
Lot: 17-270499, 17-270500, 17-270503, 17-270511, 17-270518, 17-270544, Exp. 7/16/2023; 17-270778, 17-270779, Exp. 7/19/2023; 17-270957, 17-270958, 17-270959, 17-270965, 17-270972, 17-270982, 17-270984, 17-270985, Exp. 7/23/2023; 17-271043, Exp. 7/24/2023; 17-271232, 17-271240, 17-271266, Exp. 7/26/2023; 17-271326, 17-271327, 17-271328, 17-271329, 17-271341, 17-271342, Exp. 7/27/2023; 17-271399, 17-271400, 17-271401, Exp. 7/30/2023; 17-271481, 17-271482, 17-271483, 17-271488, 17-271489, 17-271491, 17-271510, Exp. 7/31/2023; 17-271590, 17-271661, Exp. 8/1/2023; 17-271655, 17-271656, 17-271668, 17-271675, 17-271677, Exp. 8/2/2023; 17-271759, Exp. 8/3/2023; 17-271825, Exp. 8/6/2023; 17-271880, 17-271881, 17-271885, Exp. 8/7/2023; 17-271939, 17-271941, 17-271942, 17-271952, 17-271961, Exp. 8/8/2023; 17-272017, 17-272018, 17-272066, Exp. 8/9/2023; 17-272107, Exp. 8/10/2023; 17-272211, Exp. 8/13/2023; 17-272354, 17-272356, 17-272365, 17-272376, 17-272380, Exp. 8/15/2023; 17-272448, 17-272450, 17-272455, 17-272467, 17-272468, Exp. 8/16/2023; 17-272532, 17-272537, 17-272548, 17-272550, Exp. 8/17/2023; 17-272597, 17-272598, 17-272602, 17-272624, 17-272644, 17-272652, Exp. 8/20/2023; 17-273020, Exp. 8/27/2023; 17-273062, 17-273066, 17-273067, Exp. 8/28/2023; 17-273234, 17-273239, 17-273240, 17-273241, 17-273243, 17-273244, Exp. 8/30/2023; 17-273410, 17-273419, 17-273420, 17-273422, 17-273435, 17-273439, Exp. 9/3/2023; 17-273609, Exp. 9/5/2023; 17-273673, 17-273701, 17-273727, Exp. 9/6/2023; 17-273860, 17-273863, 17-273864, 17-273868, Exp. 9/10/2023; 17-273976, Exp. 9/11/2023; 17-274051, Exp. 9/12/2023.
More code info
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