Teligent Pharma, Inc. recalls Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bott
Recalled March 30, 2022 · FDA recall D-0692-2022 · 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
30,497 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%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer(s)
Teligent Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →