December 2018 FDA Recall Drug by Cipla Limited
D-0382-2019 - Failed Dissolution Specifications.
This Class II drug recall was voluntarily initiated by Cipla Limited on December 14, 2018 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0382-2019
Failed Dissolution Specifications.
12-14-2018
12-26-2018
4800 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cipla Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
07-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
Batch or Lot Expiration Information
Lot# : GG80257, Exp. 12/2019
