Status
Terminated
Drug Enforcement D-1036-2013
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Classification
Class II
Report Date
September 18, 2013
Termination Date
April 24, 2014
Product Information
- Product description
- 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
- Product quantity
- 1680 boxes
- Reason for recall
- LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Natiowide
Location & Firm
- Recalling firm
- Qualitest Pharmaceuticals
- Address
-
120 Vintage Dr NE, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1036-2013
- Event ID
- 65948
- Recall initiation date
- August 8, 2013
- Center classification date
- September 12, 2013
- Code info
- Lot Number 21230-2, Exp. DEC 2015
- More code info
- —