D-811-2013 Class II Terminated
FDA drug recall D-811-2013 was initiated by Med Prep Consulting, Inc. on March 14, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; potential for mold contamination The recall status is terminated (terminated May 11, 2018). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- March 14, 2013
- Termination Date
- May 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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 Pattern
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
Code Information
All lots