FDA recall D-1743-2019

Product

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

Reason for recall

Temperature Abuse: Complaints received of liquidy texture.

Distribution

Nationwide with the United States

Key facts

Status

Terminated

Initiation date

2019-08-07

Report date

2019-08-21

Termination date

2020-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1743-2019