D-0719-2023 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
- 13772 bags
Product Description
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
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 # 37-883198, 37-883202, 37-883203, 37-883204, Exp 04/30/2023; 37-883799, Exp 05/02/2023; 37-884159, Exp 05/03/2023; 37-884888, 37-884892, 37-884899, 37-884901, Exp 05/07/2023; 37-886836, 37-886855, 37-886861, Exp 05/15/2023; 37-887381, Exp 05/16/2023; 37-887664, Exp 05/17/2023; 37-888256, 37-888259, 37-888267, Exp 05/21/2023; 37-888624, 37-888625, Exp 05/22/2023; 37-890038, 37-890041, 37-890042, Exp 05/28/2023; 37-890331, 37-890336, 37-890350, Exp 05/29/2023; 37-891163, Exp 05/31/2023; 37-892008, 37-892012, 37-892015, Exp 06/05/2023; 37-892882, 37-892884, Exp 06/07/2023