D-0708-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- June 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3865 bags
Product Description
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 37-883926, Exp 05/02/2023; 37-886032, Exp 05/10/2023; 37-887681, Exp 05/17/2023; 37-888317, Exp 05/21/2023; 37-890906, Exp 05/30/2023; 37-892146, Exp 06/05/2023; 37-892507, Exp 06/06/2023; 37-894483, Exp 06/13/2023; 37-896595, Exp 06/21/2023; 37-898568, Exp 06/29/2023