Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-83...
FDA Recall #D-0571-2016 — Class III — December 15, 2015
Product Description
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Reason for Recall
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Recalling Firm
Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
39,187 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated