Clotrimazole and Betamethasone Dipropionate Cream USP recalled over temperature-control failures

Recall date

August 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Glenmark Pharmaceuticals Inc., USA recalls Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Phar…

Recall number

D-1743-2019

FDA classification

Class III

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide with the United States

Why it was recalled

Temperature Abuse: Complaints received of liquidy texture.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17