FDAClass IIOctober 25, 2017

methylPREDNIsolone ACETATE recall: Sterility Concern

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

Why was methylPREDNIsolone ACETATE recalled?

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

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: 04252017@1, exp 5/9/2018

Product
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Recalling firm
RXQ Compounding LLC
Quantity
945 vials
Distribution
TX, LA, PA, MA, FL, and OH
Recall date
October 25, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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