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Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent P...

FDA Recall #D-0847-2022 — Class II — April 21, 2022

Recall #D-0847-2022 Date: April 21, 2022 Classification: Class II Status: Ongoing

Product Description

Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67

Reason for Recall

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Recalling Firm

McKesson Corporation dba McKesson Drug Company — Memphis, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

13, 200 tubes

Distribution

Nationwide in the United States including Guam and the Northern Mariana Islands.

Code Information

Lots: 15720, Exp.: 06/30/2022; 16449 Exp.: 02/28/2023; 16450, Exp.: 02/26/2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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