Drug product
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
D-0563-2016
Product summary
- Event
- Event 72818
- Status
- Terminated
- Classification
- Class III
- Quantity
- 265 Drums
- Official record key
drug-enforcement:D-0563-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Code information: Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.
Distribution pattern: Distributed in the US including: CA, IL & NC; Canada
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications