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Class III: unlikely to cause harmTerminated

Boehringer Ingelheim Roxane OXYCODONE HYDROCHLORIDE C II Oral Solution Recall

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only

Boehringer Ingelheim Roxane Inc · Columbus, OH

Risk level
Class III
Reported by FDA
Aug 6, 2014
Recall ID
D-1486-2014
Check your lot numberHow we source this data

Summary

Boehringer Ingelheim Roxane recalled OXYCODONE HYDROCHLORIDE C II Oral Solution starting Jul 28, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1486-2014 on Aug 6, 2014. Reason: Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Status: Terminated.

Why it was recalled

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

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.

Lot numbers, UPCs & expiration codes

Lot #: 360241A, Expiry: 05/2015.

Where it was sold

U.S. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1486-2014
Classification
Class III
Status
Terminated
Recall initiated
Jul 28, 2014
FDA report date
Aug 6, 2014
Quantity
2,149 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Boehringer Ingelheim Roxane Inc

Original FDA data

Every field from FDA enforcement report D-1486-2014, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
68879
Address
1809 Wilson Rd
Code information
Lot #: 360241A, Expiry: 05/2015.
Postal code
43228-9579
Report date
Aug 6, 2014
Product type
Drugs
Recall number
D-1486-2014
Classification
Class III
Recalling firm
Boehringer Ingelheim Roxane Inc
Product quantity
2,149 Bottles
Termination date
May 29, 2015
Reason for recall
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
U.S. Nationwide
Recall initiation date
Jul 28, 2014
Initial firm notification
Letter
Center classification date
Jul 28, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1486-2014, published Aug 6, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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