Mylan Recalls Amiodarone Hydrochloride Injection Due to Labeling Mix-Up
Mylan Institutional LLC is recalling Amiodarone Hydrochloride Injection due to a labeling error where cartons may contain the wrong medication.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Mylan Institutional LLC is recalling 13,682 cartons of Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vials. The recall is due to a labeling mix-up where cartons labeled as Tranexamic Acid Injection, USP may contain vials of Amiodarone HCl Injection, USP, and cartons labeled as Amiodarone HCl Injection, USP may contain vials of Tranexamic Acid Injection, USP.
The affected lots are 191207, 191221, 191223 (Exp. 11/2021) and 200120 (Exp. 12/2021). The product was distributed nationwide. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If you have received this product, contact your healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. Do not use the product until you have confirmed the correct medication is in the carton.
The recalled product
- Product
- AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Injection
- Affected units
- 13,682
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 191207
- 191221
- 191223 Exp. 11/2021
- 200120 Exp. 12/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mylan Institutional LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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