PHENYLephrine HCl 10mg added to 0 — Class II drug recall D-0927-2023
Terminated recall by New England Life Care, Inc. dba Advanced Compounding Solutions, reported 2023-07-26, distributed nationwide. CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of producti
| Recall number | D-0927-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | New England Life Care, Inc. dba Advanced Compounding Solutions, Woburn, MA, United States |
| Recall initiated | 2023-07-10 |
| Classified | 2023-07-19 |
| Reported by FDA | 2023-07-26 |
| Terminated | 2023-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 82 bags |
| Reason classes | cgmp |
| NDC | 71546-0450-25 |
| Lot numbers | 20230524-6FBB77 |
| Expiration dates | 2023-10-21 |
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 for recall
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0927-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.