December 2016 FDA Recall Drug by Amneal Pharmaceuticals Llc
D-0693-2017 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Llc on December 12, 2016 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-0693-2017

Reason for Recall
Failed Dissolution Specifications
Initiated
12-12-2016
Reported
05-10-2017
Quantity
105,215 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76627
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.
Amneal Pharmaceuticals LLC
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 within the US and PR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-11-2019
Product Description About Product Description
Full technical description of the product.
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

Batch or Lot Expiration Information

Lot# : a) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730A, AR160731A, AR160732A, Exp. 05/2018. b) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730B, 5/2018.