D-0563-2016 Class III Terminated
FDA drug recall D-0563-2016 was initiated by Avantor Performance Materials Inc on Oct 30, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specifications results for impurities. The recall status is terminated (terminated Dec 19, 2016). Affected quantity: 265 Drums.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 13, 2016
- Initiation Date
- Oct 30, 2015
- Termination Date
- Dec 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 Drums
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Distribution Pattern
Distributed in the US including: CA, IL & NC; Canada
Code Information
Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0563-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026