PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 21, 2019 Initiated: August 7, 2019 #D-1743-2019

Product Description

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.

Details

Units Affected
31,224 tubes
Distribution
Nationwide with the United States
Location
Mahwah, NJ

Frequently Asked Questions

What product 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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 31,224 tubes.
Why was this product recalled?
Temperature Abuse: Complaints received of liquidy texture.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2019. Severity: Low. Recall number: D-1743-2019.