Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.

FDA recall notice · announced October 16, 2019 · Mylan Laboratories Limited (sterile Products Division)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 7008334, Exp April 2020; 7008417, Exp Oct 2020
Quantity: 19,165 vials
Status: Terminated
Products in this recall event:
- Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60. (D-0139-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.