fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Centr...

FDA Recall #D-0012-2024 — Class II — September 21, 2023

Recall #D-0012-2024 Date: September 21, 2023 Classification: Class II Status: Terminated

Product Description

fentaNYL in 0.9% sodium chloride, 1,000 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

Reason for Recall

Lack of assurance of sterility:

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

5,378 100 mL bags

Distribution

Nationwide in the USA

Code Information

Lot: 17-275314, 17-275319, 17-275320, 17-275324, 17-275327, 17-275328, 17-275349, Exp. 10/3/2023; 17-275510, 17-275531, 17-275536, 17-275541, 17-275548, Exp. 10/5/2023; 17-275656, Exp. 10/8/2023; 17-275714, Exp. 10/9/2023; 17-275766, 17-275786, 17-275787, 17-275802, Exp. 10/10/2023; 17-275918, 17-275926, Exp. 10/12/2023; 17-275951, Exp. 10/13/2023; 17-275966, 17-275975, 17-275977, Exp. 10/15/2023; 17-276103, Exp 10/17/2023.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated