Recalls / Class II
Class IID-1036-2013
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
- Affected lot / code info
- Lot Number 21230-2, Exp. DEC 2015
Why it was recalled
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Recalling firm
- Firm
- Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 1680 boxes
- Distribution pattern
- Natiowide
Timeline
- Recall initiated
- 2013-08-08
- FDA classified
- 2013-09-12
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1036-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.