Magnesium Sulfate 7-Hydrate — Class III drug recall D-0563-2016
Terminated recall by Avantor Performance Materials Inc, reported 2016-01-13, distributed in CA, IL, NC. Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
| Recall number | D-0563-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avantor Performance Materials Inc, Center Valley, PA, United States |
| Recall initiated | 2015-10-30 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-12-19 |
| Distributed | CA, IL, NC |
| Countries outside the US | CA |
| Quantity | 265 drums |
| Reason classes | specification failure |
| Lot numbers | 0000115590, 0000117563 |
| Expiration dates | 2017-05-10 |
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 for recall
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0563-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.