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
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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