Why it was recalled
Defective delivery system; product is not foaming or is coming out as liquid.
Product description
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Lot numbers, UPCs & expiration codes
Lot 14190067, exp Jul-2021
Where it was sold
Nationwide
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-0619-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 15, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- a) 480 packs; b) 240 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0619-2020, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84282
- Address
- 750 Corporate Dr
- Code information
- Lot 14190067, exp Jul-2021
- Postal code
- 07430-2009
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0619-2020
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- a) 480 packs; b) 240 packs
- Termination date
- Mar 15, 2024
- Reason for recall
- Defective delivery system; product is not foaming or is coming out as liquid.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 10, 2019