Status
Terminated
Drug Enforcement D-0929-2023
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Classification
Class II
Report Date
July 26, 2023
Termination Date
December 4, 2023
Product Information
- 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;
- Product quantity
- 209 Bags
- Reason for recall
- CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Address
-
4 Constitution Way Ste L, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0929-2023
- Event ID
- 92690
- Recall initiation date
- July 10, 2023
- Center classification date
- July 19, 2023
- Code info
- Lot # 20230524-0113AB, Exp 22AUG2023
- More code info
- —