FDAClass IIApril 28, 2021

Flurandrenolide Ointment USP recall: Impurity Out of Spec

Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60

Why was Flurandrenolide Ointment USP recalled?

Failed Impurities/Degradation Specifications:

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #13974 EXP 7/2021

Product
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Recalling firm
Teligent Pharma, Inc.
Quantity
3432 tubes
Distribution
Distributed Nationwide in the USA
Recall date
April 28, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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