Status
Ongoing
Drug Enforcement D-0124-2025
Superpotent Drug and Subpotent Drug: potency failures obtained
Classification
Class II
Report Date
December 18, 2024
Termination Date
—
Product Information
- Product description
- Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Product quantity
- 42,331 bottles
- Reason for recall
- Superpotent Drug and Subpotent Drug: potency failures obtained
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States and Puerto Rico
Location & Firm
- Recalling firm
- Viatris Inc
- Address
-
1000 Mylan Blvd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0124-2025
- Event ID
- 95768
- Recall initiation date
- November 18, 2024
- Center classification date
- December 12, 2024
- Code info
- Lot #: a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025
- More code info
- —