Status
Ongoing
Drug Enforcement D-0941-2023
Defective Delivery System
Classification
Class II
Report Date
August 2, 2023
Termination Date
—
Product Information
- Product description
- Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
- Product quantity
- 2844 units
- Reason for recall
- Defective Delivery System
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Address
-
550 Hills Dr Ste 104b, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0941-2023
- Event ID
- 92581
- Recall initiation date
- June 22, 2023
- Center classification date
- July 24, 2023
- Code info
- Lot #: 220151, 220152, 220153, Exp. Date 11/2024
- More code info
- —