FDA Recall D-1576-2020
Mylan Institutional LLC · Rockford, IL
Class I — life-threatening Terminated 863 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
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.
Recall record
- Recall number
D-1576-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2020-08-17
- Classified by FDA Center
- 2020-09-11
- FDA published
- 2020-09-09
- Terminated
- 2022-12-28
- Recalling firm
- Mylan Institutional LLC
- Firm location
- Rockford, IL
Drug identification
- Brand name(s)
- TRANEXAMIC ACID
- Generic name(s)
- TRANEXAMIC ACID
- Manufacturer(s)
- Mylan Institutional LLC
- NDC(s)
67457-197- Route(s)
- INTRAVENOUS