Drug product
Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
D-1031-2013
Product summary
- Event
- Event 66188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 590 Vials
- Official record key
drug-enforcement:D-1031-2013
Official wording
Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Code information: Lot# 130613@38, Use By: 12/10/2013
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Microbial contamination
microbial contamination
-
Sterility assurance
Lack of Assurance of Sterility