Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., ...
FDA Recall #D-0236-2017 — Class II — December 22, 2016
Product Description
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Reason for Recall
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Recalling Firm
Sandoz Incorporated — Broomfield, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
96 bottles
Distribution
MS and OH.
Code Information
Lot GG1539
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated