D-0122-2025 Class II Ongoing
FDA drug recall D-0122-2025 was initiated by Viatris Inc on November 18, 2024 and is designated Class II. Reason for recall: Superpotent Drug and Subpotent Drug: potency failures obtained The recall status is ongoing. Affected quantity: 55,032 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2024
- Initiation Date
- November 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55,032 bottles
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.
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Distribution Pattern
Nationwide within the United States and Puerto Rico
Code Information
Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025