FDAClass IIIJuly 20, 2016

Oxycodone HCl recall: Impurity Out of Spec

Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41

Why was Oxycodone HCl recalled?

Failed Impurities/Degradation Specification; 9 month stability

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 #560185A; Exp. 6/30/2017

Product
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Recalling firm
West-Ward Columbus Inc
Quantity
1,182 bottles
Distribution
Nationwide
Recall date
July 20, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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