Why it was recalled
Discoloration
Product description
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Lot numbers, UPCs & expiration codes
Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
Where it was sold
Nationwide in the US
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-0659-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 24, 2024
- FDA report date
- Sep 25, 2024
- Quantity
- 3,984 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rubicon Research Private Limited
Original FDA data
Every field from FDA enforcement report D-0659-2024, exactly as published.
Show all FDA fields
- City
- Ambarnath
- Status
- Ongoing
- Country
- India
- Event ID
- 95217
- Address
- 4 & K30 5 Plot No K - 30
- Code information
- Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
- Report date
- Sep 25, 2024
- Product type
- Drugs
- Recall number
- D-0659-2024
- Classification
- Class III
- Recalling firm
- Rubicon Research Private Limited
- Product quantity
- 3,984 bottles
- Reason for recall
- Discoloration
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Aug 24, 2024
- Initial firm notification
- Letter
- Center classification date
- Sep 13, 2024