FDA Recall D-0619-2024

Amerisource Health Services LLC · Columbus, OH

Class I — life-threatening Ongoing 688 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.

Lot / code: [100 count bottles]: Lot 17221738, Exp 07/31/2024; Lot 17222494, Exp 10/31/2024; Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025; [500 count bottles]: Lot 17221823, Lot 17221830, Exp 07/31/2024; Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2024; Lot 17230796, Lot 17230820, Exp 02/28/2025; Lot 17230825, Lot 17230833, Lot 17230840, Exp 03/31/2025; Lot 17231537, Lot 17231540, Lot 17231719, Lot 17231737, Exp 06/30/2025; Lot 17232111, Lot 17232164, Exp 09/30/2025

Quantity: 61,231 bottles

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0619-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: US Nationwide.
Recall initiated: 2024-06-25
Classified by FDA Center: 2024-07-28
FDA published: 2024-08-07
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): POTASSIUM CHLORIDE
Generic name(s): POTASSIUM CHLORIDE
Manufacturer(s): BluePoint Laboratories
NDC(s): 68001-396
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls