Why it was recalled
Labeling: Missing Label; missing label on blister card
Product description
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Lot numbers, UPCs & expiration codes
The affected product consists of lot #261739A, expiration date OCT 2014.
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-882-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 14, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 14,619 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Roxane Inc
Original FDA data
Every field from FDA enforcement report D-882-2013, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 65467
- Address
- 1809 Wilson Rd
- Code information
- The affected product consists of lot #261739A, expiration date OCT 2014.
- Postal code
- 43228-9579
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-882-2013
- Classification
- Class III
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Product quantity
- 14,619 cartons
- Termination date
- Jun 23, 2014
- Reason for recall
- Labeling: Missing Label; missing label on blister card
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 14, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 12, 2013