D-0927-2023 Class II Terminated
FDA drug recall D-0927-2023 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: 82 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
- 82 Bags
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;
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 # 20230524-6FBB77, Exp 21OCT2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0927-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026