CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
K Effervescent Tablets, 25 meq Potassium (977 mg) recalled
Qualitest Pharmaceuticals is recalling K Effervescent Tablets, 25 meq Potassium (977 mg), Orange Flavored, Potassium Bicarbonate. 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-1036-2013
- 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
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
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, CT 06409
Where it was distributed
Natiowide
Questions about this recall
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 65948This product is part of a recall event; the main page for the event is Effervescent Potassium/Chloride Tablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Effervescent Potassium/Chloride Tablets recalled | Qualitest Pharmaceuticals | Packaging Defects | AL |
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