FDAClass IIJanuary 5, 2022

Betamethasone Dipropionate recall

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

Why was Betamethasone Dipropionate recalled?

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

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 # 16569, Exp 9/2022

Product
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
Recalling firm
Teligent Pharma, Inc.
Quantity
3,792 bottles
Distribution
Distributed Nationwide in the USA
Recall date
January 5, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls