April 2019 FDA Recall Carvedilol by Zydus Pharmaceuticals Usa Inc
D-1242-2019 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on April 22, 2019 for the product Carvedilol. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1242-2019

Reason for Recall
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Initiated
04-22-2019
Reported
05-01-2019
Quantity
7668 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82682
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2021
Product Description About Product Description
Full technical description of the product.
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05

Batch or Lot Expiration Information

Lot# : Z803518, Exp 08/2020

Affected Packages Involved in this Recall

68382-092-17 Carvedilol
68382-092-01 Carvedilol
68382-092-05 Carvedilol
68382-093-17 Carvedilol
68382-093-05 Carvedilol
68382-093-01 Carvedilol
68382-094-17 Carvedilol
68382-094-01 Carvedilol
68382-094-05 Carvedilol
68382-095-17 Carvedilol
68382-095-01 Carvedilol
68382-095-05 Carvedilol