Recalls / Class II
Class IID-0847-2022
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
- Affected lot / code info
- Lots: 15720, Exp.: 06/30/2022; 16449 Exp.: 02/28/2023; 16450, Exp.: 02/26/2023
Why it was recalled
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recalling firm
- Firm
- McKesson Corporation dba McKesson Drug Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4853 Crumpler Rd, N/A, Memphis, Tennessee 38141-8301
Distribution
- Quantity
- 13, 200 tubes
- Distribution pattern
- Nationwide in the United States including Guam and the Northern Mariana Islands.
Timeline
- Recall initiated
- 2022-04-21
- FDA classified
- 2022-05-05
- Posted by FDA
- 2022-05-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0847-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.