FDA Drug recall D-920-2013
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmace…
- FDA Drug
- Class I
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class I recall of Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmace… by Fresenius Kabi Usa, citing presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-920-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-05-25 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Identifiers
| code_info | Lot #: 6103882, Exp 10/14 |
|---|
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-920-2013%22
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