FDAClass IINovember 12, 2014

DMPS-preservative free recall: Sterility Concern

DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

Why was DMPS-preservative free recalled?

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

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 #: 20140724@24/5, discard date: 10/22/2014; Lot #: 20140724@25, discard date: 10/22/2014; Lot #: 20140826@12, discard date: 11/24/2014.

Product
DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Recalling firm
Oregon Compounding Centers, Inc. dba Creative Compounds
Quantity
280 mL
Distribution
Oregon, Washington
Recall date
November 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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