FDA Recall D-920-2013
Fresenius Kabi USA, LLC · Lake Zurich, IL
Class I — life-threatening Terminated 1020 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-920-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-05-25
- Classified by FDA Center
- 2013-08-23
- FDA published
- 2013-09-04
- Terminated
- 2016-03-10
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL