FDA-Drug2024-12-18Class II

Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Viatris Inc
Hazard

Superpotent Drug and Subpotent Drug: potency failures obtained

Sold states
Nationwide within the United States and Puerto Rico
Affected count
63,077 bottles
Manufactured in
1000 Mylan Blvd, Canonsburg, PA, United States
Products
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0125-2025

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