D-0847-2022 Class II Ongoing
FDA drug recall D-0847-2022 was initiated by McKesson Corporation Dba McKesson Drug Company on Apr 21, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 13, 200 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- Apr 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13, 200 tubes
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.
Distribution Pattern
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0847-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026