FDAClass IIMarch 25, 2015

RIFAMPIN for Injection recall: Sterility Concern

RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage…

Why was RIFAMPIN for Injection recalled?

Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

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 # VRIA002; Exp. 08/16, VRIA003; Exp. 09/16, VRIA004; Exp. 09/16

Product
RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage…
Recalling firm
Heritage Pharmaceuticals, Inc.
Quantity
24,344 vials
Distribution
Nationwide
Recall date
March 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls