October 2016 FDA Recall Prednisone by West-ward Pharmaceutical
D-0008-2017 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by West-ward Pharmaceutical on October 3, 2016 for the product Prednisone. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0008-2017
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
10-03-2016
10-12-2016
15,109 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-Ward Pharmaceutical
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
12-18-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
Batch or Lot Expiration Information
Lot# 660621A, Exp 01/31/18
