Recalls / Class III
Class IIID-882-2013
Product
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
- Brand name
- Prednisone
- Generic name
- Prednisone
- Active ingredient
- Prednisone
- Route
- Oral
- NDCs
- 0054-0017, 0054-4741, 0054-4742, 0054-4728, 0054-0018, 0054-0019, 0054-3722, 0054-3721, 0054-8739, 0054-8740 +1 more
- FDA application
- ANDA080352
- Affected lot / code info
- The affected product consists of lot #261739A, expiration date OCT 2014.
Why it was recalled
Labeling: Missing Label; missing label on blister card
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 14,619 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-06-14
- FDA classified
- 2013-08-12
- Posted by FDA
- 2013-08-21
- Terminated
- 2014-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-882-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.