Why it was recalled
Failed Impurities/Degradation Specification; 9 month stability
Product description
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Lot numbers, UPCs & expiration codes
Lot #560185A; Exp. 6/30/2017
Where it was sold
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-1441-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 19, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 1,182 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-1441-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 74253
- Address
- 1809 Wilson Rd
- Code information
- Lot #560185A; Exp. 6/30/2017
- Postal code
- 43228-9579
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1441-2016
- Classification
- Class III
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 1,182 bottles
- Termination date
- Feb 2, 2017
- Reason for recall
- Failed Impurities/Degradation Specification; 9 month stability
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
- Distribution pattern
- Nationwide
- Recall initiation date
- May 19, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2016