FDAClass IISeptember 25, 2013

NA Ascorbate 500 mg/mL recall: Sterility Concern

NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183

Why was NA Ascorbate 500 mg/mL recalled?

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

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 # 130613-8, Exp 12/10/2013

Product
NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
Recalling firm
Medaus, Inc.
Quantity
8750 mL
Distribution
Nationwide
Recall date
September 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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