Product Detail

Product Description NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Recall Number D-983-2013

Classification Class II

Code Info 03282013@8, 02282013@2, 04012013@22, 05022013@22, 05012013@38

Product Distributed Qty

Reason For Recall Lack of Assurance of Sterility; FDA inspectional findings resulted
in concerns associated with quality control procedures that impacted sterility assurance

Event Detail

Event Id 65876

Product Type Drugs

Status Ongoing

Recalling Firm

Beacon Hill Medical Pharmacy, P.C.
City Southfield
State MI
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-07-26

Initial Firm Notification of Consignee or Public Telephone

Distribution Pattern USA nationwide