Magnesium Sulfate Injection — Class I drug recall D-920-2013
Terminated recall by Fresenius Kabi USA, LLC, reported 2013-09-04, distributed nationwide. Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual r
| Recall number | D-920-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2013-05-25 |
| Classified | 2013-08-23 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2016-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 15,625 vials |
| Reason classes | foreign material, specification failure |
| NDC | 63323-0064-50 |
| Lot numbers | 10/14, 6103882 |
Product
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
Reason for recall
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
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-920-2013. 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.