Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,…
Lupin Pharmaceuticals Inc. · Failed content uniformity specifications.
- Status
- Ongoing
- City
- Naples
- State
- FL
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99544
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Address 1
- 5801 Pelican Bay Blvd Ste 500
- Address 2
- N/A
- Postal code
- 34108-2734
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- USA Nationwide
- Recall number
- D-0789-2026
- Product quantity
- 5082 tubes
- Reason for recall
- Failed content uniformity specifications.
- Recall initiation date
- 20260803
- Center classification date
- 20260826
- Report date
- 20260902
- Code info
- Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
- Product description
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
- Harmonized identifiers (openFDA)
- Application number
- ANDA210208
- Brand name
- CLOBETASOL PROPIONATE
- Generic name
- CLOBETASOL PROPIONATE
- Manufacturer name
- Lupin Pharmaceuticals, Inc.
- Product NDC
- 68180-956
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Substance name
- CLOBETASOL PROPIONATE
- RxCUI
- 861495
- SPL ID
- 7b59c4a0-68c3-4423-adea-a4e2d5b1f96d
- SPL set ID
- 0a267001-0bff-471c-8852-808e6e3ea37c
- Package NDC
- 68180-956-01, 68180-956-02, 68180-956-03, 68180-956-04
- Is original packager
- true
- UNII
- 779619577M