Drug product
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
D-0941-2023
Product summary
- Event
- Event 92581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2844 units
- Official record key
drug-enforcement:D-0941-2023
Official wording
Reason: Defective Delivery System
Code information: Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Defective Delivery System