D-1743-2019 Class III Terminated
FDA drug recall D-1743-2019 was initiated by Glenmark Pharmaceuticals Inc., USA on August 7, 2019 and is designated Class III. Reason for recall: Temperature Abuse: Complaints received of liquidy texture. The recall status is terminated (terminated November 9, 2020). Affected quantity: 31,224 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- August 7, 2019
- Termination Date
- November 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,224 tubes
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.
Distribution Pattern
Nationwide with the United States
Code Information
Lot #: 05180734, Exp. 03/2020