D-0139-2020 Class II Terminated
FDA drug recall D-0139-2020 was initiated by Mylan Laboratories Limited (Sterile Products Division) on October 7, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product. The recall status is terminated (terminated March 9, 2023). Affected quantity: 19,165 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2019
- Initiation Date
- October 7, 2019
- Termination Date
- March 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,165 vials
Product Description
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Reason for Recall
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020