D-0722-2023 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
- 9037 bags
Product Description
vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6076-1.
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 # 37-883390, 37-883435, Exp 05/01/2023; 37-884157, Exp 05/03/2023; 37-885716, 37-886036, 37-886039, Exp 05/09/2023; 37-887499, 37-887500, Exp 05/16/2023; 37-887778, Exp 05/17/2023; 37-888105, Exp 05/18/2023; 37-889216, Exp 05/23/2023; 37-890923, 37-890928, 37-890936, Exp 05/30/2023; 37-891271, Exp 05/31/2023; 37-892649, Exp 06/06/2023; 37-892962, Exp 06/07/2023; 37-893966, 37-893967, 37-893969, 37-893998, Exp 06/12/2023; 37-896160, 37-896162, 37-896171, Exp 06/20/2023