FDAClass IIIJune 26, 2019

Betamethasone Dipropionate Ointment USP recall: Impurity Out of Spec

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only…

Why was Betamethasone Dipropionate Ointment USP recalled?

Failed Impurities/Degradation Specifications

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 11852, exp date 08/2020

Product
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only…
Recalling firm
Teligent Pharma, Inc.
Quantity
9360 tubes
Distribution
Nationwide
Recall date
June 26, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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