FDA-Drug2013-07-31Class II

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

Hazard

Lack of Assurance of Sterility; potential for mold contamination

Sold states
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
Affected count
N/A
Manufactured in
1540 W Park Ave Ste 5, N/A, Tinton Falls, NJ, United States
Products
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712

Official notice

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

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