FDAClass IIIJanuary 27, 2016

Lindane recall

Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60

Why was Lindane recalled?

Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017

Product
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Recalling firm
Morton Grove Pharmaceuticals, Inc.
Quantity
39,187 bottles
Distribution
Nationwide and Puerto Rico
Recall date
January 27, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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