Recalls / Class II
Class IID-0008-2017
Product
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
- 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
- Lot # 660621A, Exp 01/31/18
Why it was recalled
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Recalling firm
- Firm
- West-Ward Pharmaceutical
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 15,109 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2016-10-03
- FDA classified
- 2016-10-06
- Posted by FDA
- 2016-10-12
- Terminated
- 2017-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0008-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.