Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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