oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was ...
FDA Recall #D-0983-2023 — Class II — July 14, 2023
Product Description
oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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
463 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-249711, Exp. 8/20/2023; 36-250340, Exp. 8/23/2023; 36-251645, Exp. 8/27/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated