Bangalore, N/A, India
Mylan Laboratories Limited (Sterile Products Division) recalls
1 recall recorded since 2018, most recently on 7 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 7 October 2019
- Terminated
- 9 March 2023
- Reason
- Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0139-2020
- Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.