D-920-2013 Class I Terminated
FDA drug recall D-920-2013 was initiated by Fresenius Kabi USA, LLC on May 25, 2013 and is designated Class I. Reason for recall: Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review. The recall status is terminated (terminated Mar 10, 2016). Affected quantity: 15,625 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 4, 2013
- Initiation Date
- May 25, 2013
- Termination Date
- Mar 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,625 vials
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 6103882, Exp 10/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-920-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026