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.
Reported: August 6, 2014 Initiated: July 28, 2014 #D-1486-2014
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.
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 2,149 Bottles
- Distribution
- U.S. Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 2,149 Bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 6, 2014. Severity: Low. Recall number: D-1486-2014.
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