Amiodarone Hydrochloride 50 mg per 1 mL injection, solution

Where the pills inside were made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Mylan Institutional LLC names for other drugs.

Repackaging site

• ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it

Recalls

• Aug 17, 2020 · Class I · Mylan Institutional LLC
  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.
  Lots: Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
• Sep 12, 2014 · Class II · Mckesson
  Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
  Lots: Lot #140502, Exp 10/31/2015

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Amiodarone: every company that makes it

Form

injection, solution, intravenous

Strength

50 mg per 1 mL

Approval

ANDA ANDA076217

On the market since

Oct 14, 2002

Package NDCs

84549-153-03

Official label

DailyMed (National Library of Medicine), updated Dec 17, 2025

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?