September 2016 FDA Recall Drug by Cadila Pharmaceuticals Limited
D-0164-2017 - Microbial Contamination of Non-Sterile Product

This Class II drug recall was voluntarily initiated by Cadila Pharmaceuticals Limited on September 9, 2016 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed in According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA and the recall is currently terminated.

Recall Number: D-0164-2017

Reason for Recall
Microbial Contamination of Non-Sterile Product
Initiated
09-09-2016
Reported
12-07-2016
Quantity
6.0kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75278
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.
Cadila Pharmaceuticals 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
According to the firm, the API distributed to two consignees in the US. See Consignee list below. Consignee List: 1). LLC LENS Phanna. Russia 2). Claris irljectable, Ahmedabad 3). CPL. Inc, USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-29-2017
Product Description About Product Description
Full technical description of the product.
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

Batch or Lot Expiration Information

Batch# Supplied Batch, 150N004; Exp. 08/20 Supplied Batch, 150N006; Exp. 09/20