D-0571-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 27, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- September 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,187 bottles
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017