D-0972-2023 Class II Terminated
FDA drug recall D-0972-2023 was initiated by Central Admixture Pharmacy Services, Inc. on July 14, 2023 and is designated Class II. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. The recall status is terminated (terminated March 28, 2025). Affected quantity: 1937 bags.
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
- 1937 bags
Product Description
oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-246733, Exp. 7/12/2023; 36-247777, 36-247779, Exp. 7/15/2023; 36-250334, Exp. 7/29/2023; 36-251383, 36-251384, Exp. 8/2/2023; 36-251990, Exp. 8/5/2023