Potassium Chloride Extended-Release Capsules Recalled Nationwide for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules (750 mg) nationwide due to failed dissolution specifications that may affect medication delivery. Approximately 36,630 bottles are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 (Severe) per the rubric. No deaths or serious injuries have been reported, preventing a higher Critical rating.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Potassium Chloride Extended-Release Capsules, USP (750 mg, 10 mEq K) distributed nationwide. The recall affects approximately 36,630 bottles supplied in 500-count bottles with NDC 68462-357-05. The product is manufactured by Glenmark Pharmaceuticals Ltd. in Pithampur, Madhya Pradesh, India.
The recall was initiated due to the product failing dissolution specifications. Extended-release capsules are designed to dissolve and release medication gradually; failure to meet dissolution specifications means the medication may not be delivered properly to the body.
Multiple lot numbers are affected, with expiration dates ranging from May 2024 through November 2024. Affected lots include 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); and 17222589, 17222605, 17222613 (Exp Nov-30-24).
Patients and healthcare providers should check if their medication matches the recalled lot numbers. If affected product is identified, consult with a healthcare provider for guidance on whether to continue using this medication and what alternatives may be available.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- dissolution-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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