Rifampin for Injection Recall: Impurity Out of Spec
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC…
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Rifampin for Injection recalled?
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
Which lot codes, UPCs or models are affected?
Lot #: 7008990, exp. date Dec-2022; 7009025, exp. date Feb-2023; 7009085, 7009086, exp. date Apr-2023
- Agency record number
- D-0774-2022
- Product
- Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC…
- Recalling firm
- Mylan Pharmaceuticals Inc
- Quantity
- 33,893 vials
- Distribution
- Nationwide in the USA
- Recall started
- April 7, 2022
- Report date
- April 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)