The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1036-2013·Announced 2013-09-18

Qualitest Recalls K Effervescent Tablets Due to Labeling Mix-up

Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets because they may be mislabeled as Potassium/Chloride Tablets.

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 error (mis-labeling) without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors.

Plain-English summary

Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets, 25 meq Potassium (977 mg), Orange Flavored. The recall is due to a labeling mix-up where these tablets may be labeled as 30 count Effervescent Potassium/Chloride Tablets.

The affected product is Lot Number 21230-2, with an expiration date of December 2015. The product was distributed nationwide. The tablets are manufactured by Tower Laboratories Ltd. for Qualitest Pharmaceuticals, Inc.

Consumers should check their medication for this specific lot number and expiration date. If the product matches the description, they should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook…
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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