FDAClass IIApril 27, 2022

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…

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?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

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

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 date
April 27, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls