FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
CARDINAL HEALTHCARE
UPC
Batch 3138326

Units Affected

1 unit

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