FDA Drug recall D-0778-2023
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way…
- FDA Drug
- Class III
- terminated
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class III recall of Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way… by New England Life Care, citing product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0778-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-05-22 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | New England Life Care |
| Distribution | US |
Product
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
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Identifiers
| code_info | Lot # 20230323-728BF8, exp. 08/20/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0778-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.