Why it was recalled
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
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
Lot numbers, UPCs & expiration codes
Lot Number 21230-2, Exp. DEC 2015
Where it was sold
Natiowide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1036-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 8, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 1680 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1036-2013, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 65948
- Address
- 120 Vintage Dr NE
- Code information
- Lot Number 21230-2, Exp. DEC 2015
- Postal code
- 35811-8216
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-1036-2013
- Classification
- Class II
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 1680 boxes
- Termination date
- Apr 24, 2014
- Reason for recall
- LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Natiowide
- Recall initiation date
- Aug 8, 2013
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2013