Recalls / Class I

Class ID-1575-2020

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Brand name: Amiodarone Hydrochloride
Generic name: Amiodarone Hydrochloride
Active ingredient: Amiodarone Hydrochloride
Route: Intravenous
NDC: 67457-153
FDA application: ANDA076217
Affected lot / code info: Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021

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.

Recalling firm

Firm: Mylan Institutional LLC
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 4901 Hiawatha Dr, N/A, Rockford, Illinois 61103-1287

Distribution

Quantity: 13,682 cartons
Distribution pattern: Nationwide

Timeline

Recall initiated: 2020-08-17
FDA classified: 2020-09-11
Posted by FDA: 2020-09-09
Terminated: 2022-12-28
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1575-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.