FDA recall D-0768-2022

Preferred Pharmaceuticals, Inc. · Class II · drug

Product

Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01

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

Key facts

Status: Terminated
Initiation date: 2022-03-23
Report date: 2022-04-20
Termination date: 2023-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0768-2022