Recalls / Class II
Class IID-0941-2023
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
- Brand name
- Diclofenac Sodium
- Generic name
- Diclofenac Sodium
- Active ingredient
- Diclofenac Sodium
- Route
- Topical
- NDC
- 62332-487
- FDA application
- ANDA212506
- Affected lot / code info
- Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Why it was recalled
Defective Delivery System
Recalling firm
- Firm
- ALEMBIC PHARMACEUTICALS, INC.
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 550 Hills Dr Ste 104b, N/A, Bedminster, New Jersey 07921-1537
Distribution
- Quantity
- 2844 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-06-22
- FDA classified
- 2023-07-24
- Posted by FDA
- 2023-08-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0941-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.