October 2016 FDA Recall Drug by Inventia Healthcare Private Limited
D-0224-2017 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Inventia Healthcare Private Limited on October 19, 2016 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed in United States and the recall is currently terminated.

Recall Number: D-0224-2017

Reason for Recall
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Initiated
10-19-2016
Reported
12-28-2016
Quantity
46,848 delayed-release capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75642
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Inventia Healthcare Private Limited
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2017
Product Description About Product Description
Full technical description of the product.
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02

Batch or Lot Expiration Information

Batch# 130/16/001, 130/16/002, 130/16/003; Exp. Date 10/17