The Recall Desk
ModerateFDA (Drugs)·D-0001-2021·Announced 2020-10-07

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.

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: 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.
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.