oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy S...
FDA Recall #D-0975-2023 — Class II — July 14, 2023
Product Description
oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
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
751 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-247802, 36-247803, Exp. 7/15/2023; 36-254395, Exp. 8/10/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated