Drug Enforcement D-0221-2025

Failed Dissolution Specifications.

Status

Ongoing

Classification

Class II

Report Date

February 12, 2025

Termination Date

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Product Information

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
Product quantity
6997 cartons
Reason for recall
Failed Dissolution Specifications.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Address
341 Mason Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0221-2025
Event ID
96201
Recall initiation date
January 30, 2025
Center classification date
February 4, 2025
Code info
Lot# T05224; Exp. 02/2026
More code info
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