Status
Terminated
Drug Enforcement D-882-2013
Labeling: Missing Label; missing label on blister card
Classification
Class III
Report Date
August 21, 2013
Termination Date
June 23, 2014
Product Information
- 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
- Product quantity
- 14,619 cartons
- Reason for recall
- Labeling: Missing Label; missing label on blister card
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Address
-
1809 Wilson Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-882-2013
- Event ID
- 65467
- Recall initiation date
- June 14, 2013
- Center classification date
- August 12, 2013
- Code info
- The affected product consists of lot #261739A, expiration date OCT 2014.
- More code info
- —