Reported Aug 6, 2014 · Terminated
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane…
Boehringer Ingelheim Roxane Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- 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
- NDC0054-0523-41
- Lot codes and dates
- Lot #: 360241A
- Expiry05/2015
- Amount recalled
- 2,149 Bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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