FDA recall D-0571-2016
Morton Grove Pharmaceuticals, Inc. · Class III · drug
Product
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
Nationwide and Puerto Rico
Key facts
- Status
- Terminated
- Initiation date
- 2015-12-15
- Report date
- 2016-01-27
- Termination date
- 2016-09-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Morton Grove, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0571-2016