FDA recall D-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

Reason for recall

LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.

Distribution

Natiowide

Key facts

Status

Terminated

Initiation date

2013-08-08

Report date

2013-09-18

Termination date

2014-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2013