Why it was recalled
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Product description
Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701
Lot numbers, UPCs & expiration codes
Lot #: 315004A, Exp 1/15/14; Lot #: 315620A, Exp 1/15/14
Where it was sold
OK
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-0489-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 2, 2013
- FDA report date
- Apr 22, 2015
- Quantity
- 100 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health
Original FDA data
Every field from FDA enforcement report D-0489-2015, exactly as published.
Show all FDA fields
- City
- Zanesville
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 70334
- Address
- 3540 East Pike
- Code information
- Lot #: 315004A, Exp 1/15/14; Lot #: 315620A, Exp 1/15/14
- Postal code
- 43701-9526
- Report date
- Apr 22, 2015
- Product type
- Drugs
- Recall number
- D-0489-2015
- Classification
- Class III
- Recalling firm
- Cardinal Health
- Product quantity
- 100 blister cards
- Termination date
- Sep 30, 2015
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701
- Distribution pattern
- OK
- Recall initiation date
- Oct 2, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 15, 2015