D-0723-2023 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
- 7632 bags
Product Description
vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
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 # 37-884151, 37-884153, Exp 05/03/2023; 37-885670, 37-885869, 37-885900, Exp 05/09/2023; 37-886271, Exp 05/11/2023; 37-886857, 37-886862, 37-886865, 37-886923, Exp 05/15/2023; 37-889190, 37-889191, Exp 05/23/2023; 37-889596, Exp 05/24/2023; 37-890482, 37-890487, 37-890488, Exp 05/29/2023; 37-891230, Exp 05/31/2023; 37-892589, 37-892590, Exp 06/06/2023; 37-893779, 37-893780, 37-893781, Exp 06/12/2023; 37-894665, 37-894667, Exp 06/14/2023; 37-895608, 37-895625, Exp 06/19/2023; 37-896519, Exp 06/21/2023