Drug recall D-0500-2021
Product
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
3193479
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 453 bottles
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Livalo – drug information
- NDC 66869-104 Livalo · Pitavastatin Calcium 1.045 mg/1 · Kowa Pharmaceuticals America, Inc.
- NDC 66869-404 Livalo · Pitavastatin Calcium 4.18 mg/1 · Kowa Pharmaceuticals America, Inc.
- NDC 66869-204 Livalo · Pitavastatin Calcium 2.09 mg/1 · Kowa Pharmaceuticals America, Inc.