Drug product
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
D-811-2013
Product summary
- Event
- Event 64640
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-811-2013
Official wording
Reason: Lack of Assurance of Sterility; potential for mold contamination
Code information: All lots
Distribution pattern: Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
Derived failure modes
-
Microbial contamination
mold contamination
-
Sterility assurance
Lack of Assurance of Sterility