Class III
Terminated
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.
- Company
- Boehringer Ingelheim Roxane Inc
- Recall Initiated
- July 28, 2014
- Posted
- August 6, 2014
- Recall Number
- D-1486-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,149 Bottles
- Firm Location
- Columbus, OH, United States
Reason for Recall
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Distribution
U.S. Nationwide
Lot / Code Info
Lot #: 360241A, Expiry: 05/2015.
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