FDA recall D-0847-2022

McKesson Corporation dba McKesson Drug Company · Class II · 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

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-04-21
Report date: 2022-05-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0847-2022