Recalling firm
Viatris Inc
Product type
Drug
Status
Ongoing
Report date
2024-12-18
Distribution
Nationwide within the United States and Puerto Rico
Firm state
PA
Product quantity
55,032 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Product description
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Code / lot info
Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.