FDAClass IIIAugust 6, 2014

Oxycodone Hydrochloride C II Oral Solution USP recall

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc.…

Why was Oxycodone Hydrochloride C II Oral Solution USP recalled?

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

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 #: 360241A, Expiry: 05/2015.

Product
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc.…
Recalling firm
Boehringer Ingelheim Roxane Inc
Quantity
2,149 Bottles
Distribution
U.S. Nationwide
Recall date
August 6, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls