Status
Terminated
Drug Enforcement D-0927-2023
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
- PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
- Product quantity
- 82 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-0927-2023
- Event ID
- 92690
- Recall initiation date
- July 10, 2023
- Center classification date
- July 19, 2023
- Code info
- Lot # 20230524-6FBB77, Exp 21OCT2023
- More code info
- —