September 2014 FDA Recall Drug by Zydus Pharmaceuticals Usa Inc
D-0289-2015 - Presence of Foreign Capsules/Tablets

This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on September 24, 2014 for the product Drug. The FDA reported the reason for recall as presence of foreign capsules/tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0289-2015

Reason for Recall
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Initiated
09-24-2014
Reported
12-10-2014
Quantity
63,648 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69585
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.
Zydus Pharmaceuticals USA Inc
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.
US Nationwide including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2017
Product Description About Product Description
Full technical description of the product.
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01

Batch or Lot Expiration Information

Lot# : MM8555, Expiry: 09/14
Lot# : MM6604, Expiry: 09/14
Lot# : MM8551, Expiry: 09/14
Lot# : MM8552, Expiry: 09/14
Lot# : MM8553, Expiry: 09/14
Lot# : MM8554, Expiry: 09/14.