Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. No illnesses or injuries have been reported, but the failed dissolution specifications for a prescription extended-release drug represent a risk of inconsistent drug delivery.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling potassium chloride extended-release capsules, USP (750 mg / 10 mEq K) in 100-count bottles (NDC 68462-357-01) due to failed dissolution specifications. Approximately 285,840 bottles distributed nationwide are affected.
Dissolution specifications are critical for extended-release medications to ensure proper drug delivery. Failure to meet these specifications means the medication may not release at the intended rate, potentially affecting the consistency and effectiveness of therapy.
The affected lots include: 17221446, 17221445, 17221393, 17221403, 17221405, 17221503, 17221508, 17221567, 17221566, 17221719, 17221731, 17221891, 17221892, 17221900, 17221992, 17222022, 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, 17222265, 17222269, 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, and 17230067, with expiration dates ranging from May 31, 2024 through November 30, 2024.
Patients taking this medication should contact their healthcare provider before stopping or changing their potassium chloride regimen. Do not use any unused product from the affected lots.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Affected units
- 285,840
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#: 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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