Recalls / Class III
Class IIID-0571-2016
Product
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
- Affected lot / code info
- Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
Why it was recalled
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Recalling firm
- Firm
- Morton Grove Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6451 Main St, N/A, Morton Grove, Illinois 60053-2633
Distribution
- Quantity
- 39,187 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-12-15
- FDA classified
- 2016-01-15
- Posted by FDA
- 2016-01-27
- Terminated
- 2016-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0571-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.