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Recall Observatory FDA recall evidence

Drug product

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

D-0847-2022

April 21, 2022

Class II

Product summary

Firm
McKesson Corporation dba McKesson Drug Company
Event
Event 89986
Status
Ongoing
Classification
Class II
Quantity
13, 200 tubes
Official record key
drug-enforcement:D-0847-2022

Official wording

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

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

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations