Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-co
Summary
The FDA issued a Class I for Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-cou by Amerisource Health Services LLC. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0619-2024
Action Date
2024-08-07
Status
Ongoing
Category
drug
Product Description
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 Info: [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 Affected: 61,231 bottles
Reason for Recall
Failed Dissolution Specifications
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-25
Company
Columbus, OH
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amerisource Health Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amerisource Health Services LLC have FDA actions?
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0619-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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