PlainRecalls
FDA Drug Moderate Class II Terminated

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

Reported: August 9, 2023 Initiated: July 14, 2023 #D-0986-2023

Product Description

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

Reason for Recall

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

Details

Units Affected
130,250 bags
Distribution
Nationwide in the USA
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 130,250 bags.
Why was this product recalled?
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2023. Severity: Moderate. Recall number: D-0986-2023.