Drug Enforcement D-1066-2023

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
PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
Product quantity
81,073 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-1066-2023
Event ID
92752
Recall initiation date
July 17, 2023
Center classification date
August 3, 2023
Code info
Lot: 17-270449, 17-270450, 17-270453, 17-270462, 17-270465, 17-270466, 17-270494, 17-270495, 17-270502, 17-270541, Exp. 7/16/2023; 17-270582, 17-270585, 17-270587, 17-270592, 17-270593, 17-270598, 17-270610, 17-270611, 17-270612, Exp. 7/17/2023; 17-270900, 17-270902, 17-270906, 17-270907, 17-270908, 17-270909, 17-270953, 17-270955, 17-270991, 17-270993, Exp. 7/23/2023; 17-271047, 17-271048, 17-271050, 17-271053, Exp. 7/24/2023; 17-271344, 17-271349, 17-271355, 17-271356, 17-271405, 17-271406, Exp. 7/31/2023; 17-271478, 17-271479, 17-271480, 17-271484, 17-271495, 17-271500, Exp. 7/31/2023; 17-271744, 17-271763, Exp. 8/3/2023; 17-271838, 17-271851, Exp. 8/6/2023; 17-271871, 17-271873, 17-271886, 17-271887, 17-271892, 17-271899, 17-271900, 17-271901, 17-271902, Exp. 8/7/2023; 17-272067, 17-272068, 17-272069, 17-272095, Exp. 8/9/2023; 17-272102, 17-272141, 17-272142, Exp. 8/10/2023; 17-272205, 17-272235, 17-272237, 17-272240, 17-272242, Exp. 8/13/2023; 17-272307, 17-272308, Exp. 8/14/2023; 17-272391, 17-272392, 17-272395, Exp. 8/15/2023; 17-272472, Exp. 8/16/2023; 17-272538, Exp. 8/17/2023; 17-272558, 17-272560, 17-272564, 17-272593, 17-272594, 17-272618, 17-272619, 17-272651, 17-272653, 17-272680, Exp. 8/20/2023; 17-272697, 17-272727, 17-272729, Exp. 8/21/2023; 17-272775, 17-272791, 17-272820, 17-272821, Exp. 8/22/2023; 17-272904, 17-272918, 17-272919, 17-272920, 17-272921, 17-272929, Exp. 8/23/2023; 17-272930, 17-272974, 17-272993, 17-272994, 17-272995, 17-272996, Exp. 8/24/2023; 17-272999, 17-273003, 17-273004, 17-273005, 17-273006, 17-273007, Exp. 8/27/2023; 17-273080, Exp. 8/28/2023; 17-273151, 17-273175, 17-273176, 17-273185, Exp. 8/29/2023; 17-273252, 17-273265, 17-273266, Exp. 8/30/2023; 17-273345, 17-273351, 17-273352, 17-273355, 17-273356, 17-273358, 17-273359, 17-273360, Exp. 8/31/2023; 17-273402, 17-273408, 17-273416, 17-273440, 17-273441, 17-273447, Exp. 9/3/2023; 17-273487, 17-273488, 17-273489, 17-273490, 17-273491, 17-273499, 17-273510, 17-273516, Exp. 9/4/2023; 17-273587, 17-273589, 17-273596, 17-273597, 17-273610, 17-273614, 17-273666, Exp. 9/5/2023; 17-273617, 17-273665, 17-273703, 17-273704, 17-273713, 17-273714, 17-273720, 17-273721, 17-273730, 17-273737, 17-273739, Exp. 9/6/2023; 17-273773, Exp. 9/7/2023; 17-273802, 17-273803, 17-273808, 17-273809, 17-273815, 17-273848, 17-273869, 17-273874, 17-273880, 17-273881, 17-273893, Exp. 9/10/2023; 17-273903, 17-273958, 17-273960, 17-273961, 17-273964, 17-273965, Exp. 9/11/2023.
More code info