FDA-Drug2024-12-18Class II
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), 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
92,512 bottles
Manufactured in
1000 Mylan Blvd, Canonsburg, PA, United States
Products
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), 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-0118-2025Don't want to check this manually?
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