D-0461-2025 Class II Ongoing
FDA drug recall D-0461-2025 was initiated by AvKARE on May 9, 2025 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 962 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2025
- Initiation Date
- May 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 962 cartons
Product Description
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide USA
Code Information
Lot # 47947, Exp 05/31/2026