Recalls / Class III
Class IIID-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
- Brand name
- Clotrimazole And Betamethasone Dipropionate
- Generic name
- Clotrimazole And Betamethasone Dipropionate
- Active ingredients
- Betamethasone Dipropionate, Clotrimazole
- Route
- Topical
- NDC
- 68462-298
- FDA application
- ANDA202894
- Affected lot / code info
- Lot #: 05180734, Exp. 03/2020
Why it was recalled
Temperature Abuse: Complaints received of liquidy texture.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- Glenmark Pharmaceuticals Inc. USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 31,224 tubes
- Distribution pattern
- Nationwide with the United States
Timeline
- Recall initiated
- 2019-08-07
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2020-11-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1743-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.