Drug product
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
D-0571-2016
Product summary
- Event
- Event 72876
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39,187 bottles
- Official record key
drug-enforcement:D-0571-2016
Official wording
Reason: Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Code information: Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of Specification