D-0984-2023 Class II Terminated

Recalled by Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Recall Details

Product Type
Drugs
Report Date
August 9, 2023
Initiation Date
July 14, 2023
Termination Date
March 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9504 bags

Product Description

oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1

Reason for Recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 36-247256, 36-247525, 36-247259, Exp. 7/14/2023; 36-247782, 36-247784, Exp. 7/15/2023; 36-247980, Exp. 7/16/2023; 36-248274, 36-248275, Exp. 7/19/2023; 36-248732, 36-248733, 36-248734, 36-248735, Exp. 7/21/2023; 36-248971, 36-248990, Exp. 7/22/2023; 36-249510, 36-249511, 36-249512, Exp. 7/24/2023; 36-249722, 36-249723, Exp. 7/26/2023; 36-251196, 36-251198, Exp. 7/30/2023; 36-251431, 36-251432, 36-251433, Exp. 8/3/2023; 36-251985, 36-251986, 36-251987, 36-251989, Exp. 8/5/2023; 36-256901, 36-256902, 36-256903, 36-256904, 36-256906, Exp. 8/20/2023