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

Recall Number: D-0189-2024

Firm: CARDINAL HEALTHCARE

Classification: Class II

Status: Terminated

Report Date: 20240103

Initiation Date: 20220126

Termination Date: 20240929

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Product Description

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

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Data source: openFDA · Updated regularly