fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admi...
FDA Recall #D-1061-2023 — Class II — July 17, 2023
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
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
8,146 bags
Distribution
Nationwide in the USA
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.