D-0778-2023 Class III Terminated
FDA drug recall D-0778-2023 was initiated by New England Life Care, Inc. Dba Advanced Compounding Solutions on May 22, 2023 and is designated Class III. Reason for recall: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride The recall status is terminated (terminated Jul 25, 2023). Affected quantity: 198.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 7, 2023
- Initiation Date
- May 22, 2023
- Termination Date
- Jul 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198
Product description
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Reason for recall
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Distribution pattern
Nationwide in the USA.
Code information
Lot # 20230323-728BF8, exp. 08/20/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0778-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026