oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture ...
FDA Recall #D-1133-2023 — Class II — August 17, 2023
Product Description
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
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
2643 bags
Distribution
Nationwide in the USA
Code Information
Lot# 36-260031, 36-260027, Exp 10/3/2023; 36-262533,36-262532, 36-262531, 36-262530, 36-262529, 36-262528, 36-262527, Exp 10/9/2023. ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated