Strides Recalls Potassium Chloride Tablets for Failed Dissolution Specifications
Strides Inc. is recalling 11,280 bottles of Potassium Chloride Extended-Release Tablets because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute safety defect like a structural failure or toxic substance.
Plain-English summary
Strides Inc. is recalling 11,280 bottles of Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg). The recall involves 100-tablet bottles with NDC 64380-860-06, lot number 7240675A, and an expiration date of 12/31/2021.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution testing ensures that a drug releases its active ingredient at the proper rate and amount; failure to meet these specifications can affect the drug's performance.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Strides Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 11,280
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)
- 7240675A
- Exp. 12/31/2021
UPCs (1)
- 0364380861065
Distribution
Distributed nationwide across the United States.
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