oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy S...

FDA Recall #D-1132-2023 — Class II — August 17, 2023

Recall #D-1132-2023 Date: August 17, 2023 Classification: Class II Status: Terminated

Product Description

oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1

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

1,996 bags.

Distribution

Nationwide in the USA

Code Information

Lot# 36-260043, 36-260039, Exp 9/8/2023; 36-262220, Exp 9/10/2023; 36-262526, 36-262525, 36-262524, Exp 9/14/2023. ;

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated