Why it was recalled
Failed Dissolution Specifications
Product description
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
Lot numbers, UPCs & expiration codes
Lot #s: 231067, 231069, Exp 04/30/2025
Where it was sold
Nationwide in the USA and Puerto rico
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-0597-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 9, 2024
- FDA report date
- Jul 24, 2024
- Quantity
- 5752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0597-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94950
- Address
- 2 Independence Way
- Code information
- Lot #s: 231067, 231069, Exp 04/30/2025
- Postal code
- 08540-6620
- Report date
- Jul 24, 2024
- Product type
- Drugs
- Recall number
- D-0597-2024
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 5752 bottles
- Termination date
- Dec 22, 2025
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
- Distribution pattern
- Nationwide in the USA and Puerto rico
- Recall initiation date
- Jul 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2024