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Class III: unlikely to cause harmTerminated

Northwind Pharmaceuticals Prednisone 20 mg Recall

Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BO…

Northwind Pharmaceuticals LLC · Indianapolis, IN

Risk level
Class III
Reported by FDA
Dec 9, 2015
Recall ID
D-0485-2016
Check your lot numberHow we source this data

Summary

Northwind Pharmaceuticals recalled Prednisone 20 mg starting Nov 10, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0485-2016 on Dec 9, 2015. Reason: Labeling: Not elsewhere classified. NDC number is incorrect on the container. Status: Terminated.

Why it was recalled

Labeling: Not elsewhere classified. NDC number is incorrect on the container.

Product description

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

Lot numbers, UPCs & expiration codes

Lot # NW 46400021, Exp 03/2018

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-0485-2016
Classification
Class III
Status
Terminated
Recall initiated
Nov 10, 2015
FDA report date
Dec 9, 2015
Quantity
40 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Northwind Pharmaceuticals LLC

Original FDA data

Every field from FDA enforcement report D-0485-2016, exactly as published.

Show all FDA fields
City
Indianapolis
State
IN
Status
Terminated
Country
United States
Event ID
72647
Address
9402 Uptown Dr Ste 1100
Code information
Lot # NW 46400021, Exp 03/2018
Postal code
46256-1042
Report date
Dec 9, 2015
Product type
Drugs
Recall number
D-0485-2016
Classification
Class III
Recalling firm
Northwind Pharmaceuticals LLC
Product quantity
40 Bottles
Termination date
Mar 29, 2017
Reason for recall
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Nov 10, 2015
Initial firm notification
E-Mail
Center classification date
Dec 2, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0485-2016, published Dec 9, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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