Mylan Recalls Tranexamic Acid Injection Due to Labeling Mix-Up
Mylan Institutional LLC is recalling 1,407 cartons of Tranexamic Acid Injection due to a labeling error that may result in the wrong medication being dispensed.
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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score due to the potential for serious adverse health consequences or death from administering the wrong medication.
Plain-English summary
Mylan Institutional LLC is recalling 1,407 cartons of Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vials. The recall is due to a labeling mix-up where cartons labeled as Tranexamic Acid Injection may contain vials of Amiodarone HCl Injection, USP, and cartons labeled as Amiodarone HCl Injection may contain vials of Tranexamic Acid Injection.
The affected product is distributed nationwide. The recall includes specific lot numbers 191207, 191221, 191223, and 200120, with expiration dates of 11/2021 and 12/2021. The product is manufactured by Mylan Institutional in Galway, Ireland, and manufactured for Mylan Institutional LLC in Rockford, IL.
Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be quarantined and not administered until further notice. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- TRANEXAMIC ACID (TRANEXAMIC ACID)
- Brand
- TRANEXAMIC ACID
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Injection
- Affected units
- 1,407
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 (5)
- 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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