Drug Enforcement D-810-2013

Non-Sterility; mold contamination

Status

Terminated

Classification

Class I

Report Date

July 31, 2013

Termination Date

May 11, 2018

Product Information

Product description
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Product quantity
403883 bags
Reason for recall
Non-Sterility; mold contamination
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA

Location & Firm

Recalling firm
Med Prep Consulting, Inc.
Address
1540 W Park Ave Ste 5, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-810-2013
Event ID
64640
Recall initiation date
March 14, 2013
Center classification date
July 19, 2013
Code info
All lots
More code info