Recalls / Class III
Class IIID-0485-2016
Product
Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53
- Affected lot / code info
- Lot # NW 46400021, Exp 03/2018
Why it was recalled
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Recalling firm
- Firm
- Northwind Pharmaceuticals LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 9402 Uptown Dr Ste 1100, Indianapolis, Indiana 46256-1042
Distribution
- Quantity
- 40 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-11-10
- FDA classified
- 2015-12-02
- Posted by FDA
- 2015-12-09
- Terminated
- 2017-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0485-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.