The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1037-2013·Announced 2013-09-18

Qualitest Recalls Effervescent Potassium Chloride Tablets Due to Labeling Error

Qualitest Pharmaceuticals is recalling 1,680 boxes of effervescent potassium chloride tablets because they may be mislabeled as a different potassium product.

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 and involves a labeling mix-up. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.

Plain-English summary

Qualitest Pharmaceuticals is recalling 1,680 boxes of Effervescent Potassium/Chloride Tablets, 25 meq Potassium Chloride (1865 mg), USP, Fruit Punch Flavor, 30 count. The recall is due to a labeling error where the product may be labeled as 30 count K Effervescent Tablets. The affected product is identified by Lot Number 21230-2 and has an expiration date of December 2015.

The product was distributed nationwide. It was manufactured by Tower Laboratories Ltd. for Qualitest Pharmaceuticals, Inc. The recall is classified as Class II by the FDA, indicating a situation in which there is a reasonable probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Consumers should check their medication cabinets for this specific product and lot number. If found, they should stop using the product and contact their healthcare provider or pharmacist for guidance on proper disposal or replacement. This recall is precautionary regarding the labeling discrepancy.

The recalled product

Product
EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL…
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
1,680

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 Number 21230-2
  • Exp. DEC 2015

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Qualitest Pharmaceuticals 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 2 products in this recall →

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