Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 1...
FDA Recall #D-0221-2025 — Class II — January 30, 2025
Product Description
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
Reason for Recall
Failed Dissolution Specifications.
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6997 cartons
Distribution
Nationwide in the USA
Code Information
Lot# T05224; Exp. 02/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated