CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Effervescent Potassium/Chloride Tablets recalled
Qualitest Pharmaceuticals is recalling Effervescent Potassium/Chloride Tablets, 25 meq Potassium Chloride (1865 mg), Potassium. The recall was initiated on 8 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1037-2013
- FDA event ID
- 65948
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Aug 2013 | Recall initiated by company | |
| 12 Sep 2013 | Classified by FDA | +35 days |
| 18 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409
Where it was distributed
Natiowide
Questions about this recall
Is Effervescent Potassium/Chloride Tablets, 25 meq Potassium Chloride (1865 mg), Potassium recalled?
Yes. Qualitest Pharmaceuticals recalled Effervescent Potassium/Chloride Tablets, 25 meq Potassium Chloride (1865 mg), Potassium on 8 Aug 2013. The recall is Class II and its status is Terminated. Recall number D-1037-2013.
Why was it recalled?
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Which lots are affected?
Lot Number 21230-2, Exp. DEC 2015
Where was it sold?
Natiowide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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