PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Ad...

FDA Recall #D-1127-2023 — Class II — August 17, 2023

Recall #D-1127-2023 Date: August 17, 2023 Classification: Class II Status: Terminated

Product Description

PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1

Reason for Recall

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

292 bags

Distribution

Nationwide in the USA

Code Information

Lot# 36-260036, Exp 10/3/2023. ;

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated