D-0718-2023 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
- 3075 bags
Product Description
vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
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 # 37-884161, Exp 05/03/2023; 37-885995, 37-885997, Exp 05/10/2023; 37-887729, Exp 05/17/2023; 37-889595, Exp 05/24/2023; 37-891272, Exp 05/31/2023; 37-892162, Exp 06/05/2023; 37-894716, Exp 06/14/2023