Status
Terminated
Drug Enforcement D-1061-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 21, 2025
Product Information
- Product description
- fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
- Product quantity
- 8,146 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-1061-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270584, 17-270586, 17-270597, 17-270613, Exp. 7/17/2023; 17-270655, 17-270659, 17-270741, Exp. 7/18/2023; 17-270872, 17-270875, Exp. 7/20/2023; 17-271040, 17-271041, 17-271042, 17-271058, 17-271066, 17-271071, 17-271080, Exp. 7/24/2023; 17-271111, 17-271148, 17-271150, 17-271151, 17-271152, 17-271166, Exp. 7/25/2023; 17-271241, 17-271267, Exp. 7/26/2023; 17-271402, 17-271407, 17-271413, 17-271429, Exp. 7/30/2023; 17-271555, 17-271556, 17-271560, 17-271594, Exp. 8/1/2023; 17-271754, Exp. 8/3/2023; 17-271797, 17-271799, 17-271821, 17-271842, Exp. 8/6/2023; 17-271888, 17-271889, Exp. 8/7/2023; 17-271949, 17-271950, Exp. 8/8/2023; 17-272021, 17-272041, Exp. 8/9/2023; 17-272285, 17-272292, 17-272309, 17-272316, Exp. 8/14/2023; 17-272705, 17-272708, 17-272709, 17-272722, 17-272725, Exp. 8/21/2023; 17-272784, 17-272810, Exp. 8/22/2023; 17-272916, Exp. 8/23/2023; 17-272981, 17-272982, 17-272983, 17-272984, Exp. 8/24/2023; 17-273144, 17-273145, 17-273158, 17-273159, 17-273165, Exp. 8/29/2023; 17-273480, 17-273485, 17-273492, 17-273494, 17-273498, Exp. 9/4/2023; 17-273567, 17-273568, 17-273578, 17-273603, Exp. 9/5/2023; 17-273767, 17-273777, 17-273781, Exp. 9/7/2023; 17-273980, Exp. 9/11/2023; 17-274130, 17-274135, Exp. 9/13/2023.
- More code info
- —