FDAClass IIMay 24, 2017

Pge1 MDV 20mcg/ml INJ recall: Sterility Concern

PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

Why was Pge1 MDV 20mcg/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 # t01-05-2017@102, Exp 7/5/2017; t02-02-2017@105, Exp 8/2/2017; t02-10-2017@121, Exp 8/2/2017.

Product
PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
Recalling firm
Key Pharmacy and Compounding Center
Quantity
5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials)
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