Why it was recalled
Temperature Abuse: Complaints received of liquidy texture.
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
Lot numbers, UPCs & expiration codes
Lot #: 05180734, Exp. 03/2020
Where it was sold
Nationwide with the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1743-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 7, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 31,224 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-1743-2019, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83526
- Address
- 750 Corporate Dr
- Code information
- Lot #: 05180734, Exp. 03/2020
- Postal code
- 07430-2009
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1743-2019
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 31,224 tubes
- Termination date
- Nov 9, 2020
- Reason for recall
- Temperature Abuse: Complaints received of liquidy texture.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Aug 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2019