December 2016 FDA Recall Drug by Sandoz Incorporated
D-0236-2017 - Failed dissolution specification

This Class II drug recall was voluntarily initiated by Sandoz Incorporated on December 22, 2016 for the product Drug. The FDA reported the reason for recall as failed dissolution specification. The product was distributed in MS and OH. and the recall is currently terminated.

Recall Number: D-0236-2017

Reason for Recall
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Initiated
12-22-2016
Reported
01-04-2017
Quantity
96 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76077
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.
Sandoz Incorporated
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.
MS and OH.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-18-2017
Product Description About Product Description
Full technical description of the product.
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

Batch or Lot Expiration Information

Lot# Lot GG1539