FDA Drug recall D-958-2013
FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Ph…
- FDA Drug
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Ph… by Beacon Hill Medical Pharmacy P C, citing lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-958-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-26 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Beacon Hill Medical Pharmacy P C |
| Distribution | US |
Product
FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Identifiers
| code_info | 03262013@11, 01212013@12, 02112013@17, 02262013@7, 03012013@17, 04102013@8, 04112013@7, 04292013@20, 05212013@4, 060420…03262013@11, 01212013@12, 02112013@17, 02262013@7, 03012013@17, 04102013@8, 04112013@7, 04292013@20, 05212013@4, 06042013@12, 06202013@3, 07152013@19, 07242013@14, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-958-2013%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.