Prescription Potassium Chloride Extended-Release Capsules Recalled for Manufacturing Deviations
Glenmark Pharmaceuticals is voluntarily recalling Potassium Chloride Extended-Release Capsules (750 mg) nationwide due to manufacturing quality deviations. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a risk-of-harm medication due to manufacturing deviations. Potassium chloride is a prescription medication where formulation or release-mechanism compromises could cause serious electrolyte imbalances. While no illnesses have been reported, the hazard is not merely theoretical.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Potassium Chloride Extended-Release Capsules, USP 750 mg (10 mEq K) in 100-count bottles (NDC 68462-357-01) due to manufacturing deviations identified during production. The recall applies to multiple lot numbers with various expiration dates ranging through September 2025.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered by the manufacturer. The firm notified the FDA of the issue on May 30, 2024, and the FDA classified the recall as Class II on July 17, 2024. No illnesses or injuries have been reported to date.
The medication was distributed nationwide. Patients currently taking this prescription medication should contact their healthcare provider or pharmacist before making any changes to their treatment. Healthcare providers should consider alternative potassium chloride products for affected patients. Patients with unused bottles should contact their pharmacy for return and disposal instructions.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- manufacturing-defect
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 #: 17230074
- 17230221
- Exp Dec-31-24
- 17230468
- 17230479
- 17230553
- 17230543
- 17230561
- Exp Jan-31-25
- 17230619
- 17230624
- Exp Feb-28-25
- 17230879
- 17230890
- 17230918
- 17230984
- 17230996
- 17231002
- 17231081
- Exp Mar-31-25
Distribution
Distributed nationwide across the United States.
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