FDA Drug recall D-1575-2020
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99)
- FDA Drug
- Class I
- terminated
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class I recall of Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99) by Mylan Institutional, citing 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 Inj….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1575-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-08-17 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional |
| Distribution | US |
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.
Reason
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.
Identifiers
| ndc | 67457-153-00 |
|---|---|
| ndc | 67457-153-03 |
| ndc | 67457-153-99 |
| ndc | 67457-153-09 |
| ndc | 67457-153-18 |
| code_info | Lot #: 191207, 191221, 191223 Exp. 11/2021; 200120 Exp. 12/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Mylan Institutional recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1575-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.