Why it was recalled
Defective Delivery System
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
Lot numbers, UPCs & expiration codes
Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Where it was sold
Nationwide within the United States
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-0941-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 22, 2023
- FDA report date
- Aug 2, 2023
- Quantity
- 2844 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
Original FDA data
Every field from FDA enforcement report D-0941-2023, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 92581
- Address
- 550 Hills Dr Ste 104b
- Code information
- Lot #: 220151, 220152, 220153, Exp. Date 11/2024
- Postal code
- 07921-1537
- Report date
- Aug 2, 2023
- Product type
- Drugs
- Recall number
- D-0941-2023
- Classification
- Class II
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Product quantity
- 2844 units
- Reason for recall
- Defective Delivery System
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2023