FDAClass IJuly 30, 2014

Oxycodone HCl Oral Concentrate recall: Labeling Error

Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock…

Why was Oxycodone HCl Oral Concentrate recalled?

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

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 #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36

Product
Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock…
Recalling firm
Shamrock Medical Solutions Group LLC
Quantity
55/1 mL/20mg/mL syringe
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Recall date
July 30, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls