Recalls / Class I
Class ID-0604-2024
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, 100-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 68462-357-01
- 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#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, 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
- 285,840 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-0604-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.