FDAFDA · Food and drugs·Recall number D-1486-2014
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
Published August 6, 2014 · Recall initiated: July 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Distributor
- U.S. Nationwide
- Lot
- Lot #: 360241A, Expiry: 05/2015.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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