January 2025 FDA Recall Potassium Chloride by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
D-0221-2025 - Failed Dissolution Specifications.

This Class II drug recall was voluntarily initiated by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories on January 30, 2025 for the product Potassium Chloride. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0221-2025

Reason for Recall
Failed Dissolution Specifications.
Initiated
01-30-2025
Reported
02-12-2025
Quantity
6997 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96201
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# T05224; Exp. 02/2026

Affected Packages Involved in this Recall

0904-7216-61 Potassium Chloride