Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
Inventia Healthcare Limited · Failed Dissolution Specifications
- Status
- Ongoing
- City
- Kalyan
- State
- N/A
- Country
- India
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99806
- Recalling firm
- Inventia Healthcare Limited
- Address 1
- Additional Ambernath Midc
- Address 2
- Ambernath East; F1-F1/1-F75/1
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
- Recall number
- D-0852-2026
- Product description
- Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
- Product quantity
- 13567 bottles
- Reason for recall
- Failed Dissolution Specifications
- Recall initiation date
- 20260903
- Center classification date
- 20260917
- Report date
- 20260923
- Code info
- Batch # RISA24002; Exp Date: 04/2027
- Harmonized identifiers (openFDA)
- Application number
- ANDA211320
- Brand name
- CHLORTHALIDONE
- Generic name
- CHLORTHALIDONE
- Manufacturer name
- Rising Pharma Holdings, Inc.
- Product NDC
- 64980-599, 64980-600
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- CHLORTHALIDONE
- RxCUI
- 197499, 197500
- SPL ID
- 6404aaa7-05c8-4f96-a091-3f07248ffbd5
- SPL set ID
- 71b1d074-0521-4cd1-beb5-fedd61f52eca
- Package NDC
- 64980-599-01, 64980-599-10, 64980-600-01
- Is original packager
- true
- Upc
- 0364980599108, 0364980599016, 0364980600019
- Nui
- N0000175359, N0000175420
- Pharm class pe
- Increased Diuresis [PE]
- Pharm class epc
- Thiazide-like Diuretic [EPC]
- UNII
- Q0MQD1073Q