Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.
Reported: January 29, 2014 Initiated: October 31, 2013 #D-1034-2014
Product Description
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.
Reason for Recall
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 121,456 vials
- Distribution
- US: Nationwide
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10.. Recalled by Fresenius Kabi USA, LLC. Units affected: 121,456 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-1034-2014.
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