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.

FDA recall notice · announced August 6, 2014 · Boehringer Ingelheim Roxane

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot #: 360241A, Expiry: 05/2015.
Quantity: 2,149 Bottles
Status: Terminated
Products in this recall event:
- 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. (D-1486-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.