FDAClass IIMay 24, 2017

Ferr Gluc MDV 60mg/ml INJ recall: Sterility Concern

FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

Why was Ferr Gluc MDV 60mg/ml INJ recalled?

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

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 # t02-13-2017@98, Exp 5/15/2017; t02-14-2017@98, Exp 5/16/2017; t02-15-2017@120, Exp 5/17/2017

Product
FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Recalling firm
Key Pharmacy and Compounding Center
Quantity
3 vials total (2/5mL vials and 1/10mL)
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Recall date
May 24, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls