FDAClass IIMarch 30, 2022

Diflorasone Diacetate Ointment USP recall: CGMP Deviations

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC…

Why was Diflorasone Diacetate Ointment USP recalled?

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

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?

Batch: 15800, Exp. 7/31/2022; 15876, 15904, 15917, 15922, Exp. 8/31/2022; 16202, 16203, Exp. 11/30/2022.

Product
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC…
Recalling firm
Teligent Pharma, Inc.
Quantity
24,304 bottles
Distribution
Nationwide in the USA and Puerto Rico
Recall date
March 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls