Teligent Pharma, Inc. recalls Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27
Recalled March 30, 2022 · FDA recall D-0690-2022 · Teligent Pharma
Hazard
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. · FDA Class II
Units
6431 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Product
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Manufacturer(s)
Teligent Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →