Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Presence of Particulate Matter: Piece of metal found in a vial
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
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