Teligent Pharma, Inc. recalls Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30
Recalled March 30, 2022 · FDA recall D-0682-2022 · 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
151,975 tubes
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
Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer(s)
Teligent Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →