Drug 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, CT 06409
D-1036-2013
Product summary
- Event
- Event 65948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1680 boxes
- Official record key
drug-enforcement:D-1036-2013
Official wording
Reason: LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Code information: Lot Number 21230-2, Exp. DEC 2015
Distribution pattern: Natiowide
Derived failure modes
-
Labeling or packaging
LABELING: Label Mix-up