Lithium Carbonate Extended-Release Tablets recalled over manufacturing violations

Recall date

January 26, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CARDINAL HEALTHCARE recalls Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharm…

Recall number

D-0189-2024

FDA classification

Class II

Brand / firm

CARDINAL HEALTHCARE

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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