D-1486-2014 Class III Terminated
FDA drug recall D-1486-2014 was initiated by Boehringer Ingelheim Roxane Inc on July 28, 2014 and is designated Class III. Reason for recall: Failed Stability Specifications: Out of specification result for preservative sodium benzoate. The recall status is terminated (terminated May 29, 2015). Affected quantity: 2,149 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 6, 2014
- Initiation Date
- July 28, 2014
- Termination Date
- May 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,149 Bottles
Product Description
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.
Reason for Recall
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Distribution Pattern
U.S. Nationwide
Code Information
Lot #: 360241A, Expiry: 05/2015.