CLASS I Drug recall · Reported 9 Sep 2020 · FDA Enforcement Report
Amiodarone Hydrochloride Injection, USP, 450 mg recalled
Mylan Institutional is recalling Amiodarone Hydrochloride Injection, USP, 450 mg/ (50 mg/mL) Single-Dose Vial (, distributed nationwide in the US. The recall was initiated on 17 Aug 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1575-2020
- FDA event ID
- 86247
- Recalling firm
- Mylan Institutional, Rockford, IL
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Aug 2020
- FDA classified
- 11 Sep 2020
- Reported
- 9 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Aug 2020 | Recall initiated by company | |
| 9 Sep 2020 | Published in enforcement report | +23 days |
| 11 Sep 2020 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 86247This product is part of a recall event; the main page for the event is Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan Institutional.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Tranexamic Acid Injection, USP, 1000 mg recalled by Mylan InstitutionalTranexamic Acid | Mylan Institutional | Packaging Defects | Nationwide |
More recalls from Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Amiodarone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Nexterone (amiodarone HCl) Premixed Injection, 150mg recalledNexterone | Baxter Healthcare | Particulate Matter | Nationwide |