FDA-Drug2025-02-12Class II
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
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Failed Dissolution Specifications.
Sold states
Nationwide in the USA
Affected count
6997 cartons
Manufactured in
341 Mason Rd, La Vergne, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2025Don't want to check this manually?
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