Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Teligent Pharma, Inc.

NDC code

52565-022-85

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0751-2021

Other Econazole recalls

See all

Class II · Moderate risk Terminated Mar 24, 2022

Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's…

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…

Preferred Pharmaceuticals, Inc. NDC 68788-7406-03 D-0771-2022

Class II · Moderate risk Terminated Mar 15, 2022

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…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-022-15 D-0682-2022

Class II · Moderate risk Terminated Apr 6, 2020

Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Reason Lack of Processing Control

The Medicine Shoppe Pharmacy D-1211-2020