Recalls / Class I
Class ID-0605-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Oral
- NDC
- 68462-357
- FDA application
- ANDA202868
- Affected lot / code info
- Lot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 36,630 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-05-30
- FDA classified
- 2024-07-17
- Posted by FDA
- 2024-07-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0605-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.