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

FDA recall notice · announced August 21, 2019 · Glenmark Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide with the United States
Lot/code information: Lot #: 05180734, Exp. 03/2020
Quantity: 31,224 tubes
Status: Terminated
Products in this recall event:
- 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, Hima (D-1743-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.