Recall: D-1743-2019

Class III - Minor Violations

Class IIIClassification

2019-08-07Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

Temperature Abuse: Complaints received of liquidy texture.

Distribution

Nationwide with the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.