Class II Recall

CARDINAL HEALTHCARE

Product
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Classification
Class II
Status
Terminated
Lot
Batch 3138326
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.