FDA Enforcement Report March 23, 2016-Recalling Firm: ePharmdium Services, LLC

Event Details

Event ID:

72973

Voluntary / Mandated:

Voluntary: Firm Initiated

Product Type:

Drugs

Initial Firm Notification of Consignee or Public:

E-Mail

Status:

Ongoing

Distribution Pattern:

Nationwide

Recalling Firm:

ePharmdium Services, LLC 

150 N Field Dr Ste 350 
Lake Forest, IL 60045-2506
United States

Recall Initiation Date:

12/31/2015

Center Classification Date:

03/17/2016

Date Terminated:

Product Details

Product Description	Recall Number	Code Information	Product Quantity	Reason for Recall
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61	D-0778-2016	Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016		Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61	D-0777-2016	Service Code 2K6134; 15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S, 15343026S, 15343129S, and 15343131S, exp 2/11/2016; 15344157S, 15344160S, and 15344209S, exp 2/12/2016; 15345036S, 15345104S, 15345106S, and 15345142S, exp 2/13/2016; 15346015S, 15346016S, 15346017S, 15346018S, 15346019S, 15346020S, 15346022S, and 15346023S, exp 2/14/2016; 15348152S, and 15348197S, exp 2/16/2016 15350046S, andmore...