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fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Tota...

FDA Recall #D-0016-2024 — Class II — September 21, 2023

Recall #D-0016-2024 Date: September 21, 2023 Classification: Class II Status: Terminated

Product Description

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1

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

60 250 mL bags

Distribution

Nationwide in the USA

Code Information

Lot: 17-275929, Exp. 10/12/2023,

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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