Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1576-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 17, 2020
- FDA report date
- Sep 9, 2020
- Quantity
- 1407 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-1576-2020, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86247
- Address
- 4901 Hiawatha Dr
- Code information
- Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021
- Postal code
- 61103-1287
- Report date
- Sep 9, 2020
- Product type
- Drugs
- Recall number
- D-1576-2020
- Classification
- Class I
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- 1407 cartons
- Termination date
- Dec 28, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2020