Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution
Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a drug quality defect. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing/quality-control failure rather than contamination or acute risk of harm. Per the rubric, Class II recalls without hospitalization reports and no reported illness are scored as Moderate (2).
Plain-English summary
Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg) distributed nationwide. The recalled product is supplied in bottles of 500 tablets with NDC 64380-861-07. Lot 7240840A with expiration date 12/31/2021 is affected. A total of 1,813 bottles have been distributed.
The recall was initiated because the tablets failed to meet United States Pharmacopeia (USP) dissolution specifications. Dissolution is a critical quality parameter for extended-release formulations that determines how quickly and completely the drug is released in the body. Failure to meet dissolution specifications may result in reduced drug bioavailability and loss of therapeutic effect.
The product is a prescription medication manufactured by Strides Shasun Limited in Bengaluru, India, and distributed by Strides Pharma Inc. in East Brunswick, New Jersey. Consumers and healthcare providers in possession of the recalled product should discontinue use and contact their pharmacy or physician for guidance on obtaining replacement medication.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Strides Pharma Inc.
- Hazard
- failed-dissolution
- reduced-bioavailability
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 (2)
- Lot 7240840A
- exp. 12/31/2021
UPCs (2)
- 0364380861065
- 0364380860068
Distribution
Distributed nationwide across the United States.
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