FDA Recall D-810-2013
Med Prep Consulting, Inc. · Tinton Falls, NJ
Class I — life-threatening Terminated 1884 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Reason for recall
Non-Sterility; mold contamination
Recall record
- Recall number
D-810-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
- Recall initiated
- 2013-03-14
- Classified by FDA Center
- 2013-07-19
- FDA published
- 2013-07-31
- Terminated
- 2018-05-11
- Recalling firm
- Med Prep Consulting, Inc.
- Firm location
- Tinton Falls, NJ