FDA recall D-811-2013

Med Prep Consulting, Inc. · Class II · drug

Product

All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712

Reason for recall

Lack of Assurance of Sterility; potential for mold contamination

Distribution

Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA

Key facts

Status
Terminated
Initiation date
2013-03-14
Report date
2013-07-31
Termination date
2018-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tinton Falls, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-811-2013