August 2016 FDA Recall Drug by West-ward Pharmaceuticals Corp.
D-1515-2016 - Labeling

This Class III drug recall was voluntarily initiated by West-ward Pharmaceuticals Corp. on August 18, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1515-2016

Reason for Recall
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Initiated
08-18-2016
Reported
09-28-2016
Quantity
32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75083
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2017
Product Description About Product Description
Full technical description of the product.
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

Batch or Lot Expiration Information

Lot# : AS1413A, AS1414A; Exp. 11/18