FDAHealthJanuary 30, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx
⚠️ Failed Dissolution Specifications.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 30, 2025
Nationwide in the USA
What's affected?
- 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
- Brand
- POTASSIUM CHLORIDE
- Lot code
- T05224
Additional details
Lot# T05224; Exp. 02/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6997 cartons.
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