NDC 67457-153
Amiodarone Hydrochloride 50 mg per 1 mL injection, solution
On the label: Mylan Institutional LLC.
Where it's 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.
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
67457-153-0067457-153-0367457-153-0967457-153-1867457-153-99- Official label
- DailyMed (National Library of Medicine), updated Jul 15, 2020
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