Drug product
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
D-0489-2015
Product summary
- Firm
- Cardinal Health
- Event
- Event 70334
- Status
- Terminated
- Classification
- Class III
- Quantity
- 100 blister cards
- Official record key
drug-enforcement:D-0489-2015
Official wording
Reason: 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.
Code information: Lot #: 315004A, Exp 1/15/14; Lot #: 315620A, Exp 1/15/14
Distribution pattern: OK
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing