D-0929-2023 Class II Terminated
FDA drug recall D-0929-2023 was initiated by New England Life Care, Inc. Dba Advanced Compounding Solutions on Jul 10, 2023 and is designated Class II. Reason for recall: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. The recall status is terminated (terminated Dec 4, 2023). Affected quantity: 209 Bags.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 26, 2023
- Initiation Date
- Jul 10, 2023
- Termination Date
- Dec 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209 Bags
Product description
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Reason for recall
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Distribution pattern
Nationwide in the USA
Code information
Lot # 20230524-0113AB, Exp 22AUG2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0929-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026