FDA Drug recall D-0927-2023
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Con…
- FDA Drug
- Class II
- terminated
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Con… by New England Life Care, citing CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0927-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-10 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | New England Life Care |
| Distribution | US |
Product
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
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Identifiers
| code_info | Lot # 20230524-6FBB77, Exp 21OCT2023 |
|---|
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-0927-2023%22
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