FDA Drug recall D-0563-2016
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200…
- FDA Drug
- Class III
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class III recall of Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200… by Avantor Performance Materials, citing failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0563-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-30 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Avantor Performance Materials |
| Distribution | CA, IL, NC |
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.
Reason
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Identifiers
| code_info | Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0563-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.