Drug product
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
D-810-2013
Product summary
- Event
- Event 64640
- Status
- Terminated
- Classification
- Class I
- Quantity
- 403883 bags
- Official record key
drug-enforcement:D-810-2013
Official wording
Reason: Non-Sterility; 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