Tranexamic Acid Injection USP recall: Particulate Matter
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP…
Why was Tranexamic Acid Injection USP recalled?
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
National Drug Code (NDC): 63323-563-10; Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 032913 (03/2015), 041613 (04/2015); 042513 (04/2015), 042613 (04/2015), 052213 (05/2015), 092612 (09/2014), 111512 (11/2014) NDC: 14789-500-10; 122911 (12/2013), 123011 (12/2013)
- Product
- Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 121,456 vials
- Distribution
- US: Nationwide
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)