D-1037-2013 Class II Terminated
FDA drug recall D-1037-2013 was initiated by Qualitest Pharmaceuticals on August 8, 2013 and is designated Class II. Reason for recall: LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets. The recall status is terminated (terminated April 24, 2014). Affected quantity: 1680 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2013
- Initiation Date
- August 8, 2013
- Termination Date
- April 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1680 boxes
Product Description
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
Reason for Recall
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Distribution Pattern
Natiowide
Code Information
Lot Number 21230-2, Exp. DEC 2015