Recalls / Class III
Class IIID-1486-2014
Product
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.
- Affected lot / code info
- Lot #: 360241A, Expiry: 05/2015.
Why it was recalled
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 2,149 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2014-07-28
- FDA classified
- 2014-07-28
- Posted by FDA
- 2014-08-06
- Terminated
- 2015-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1486-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.