Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles
Summary
The FDA issued a Class II for Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC by Viatris Inc. Reason: Superpotent Drug and Subpotent Drug: potency failures obtained.
Details
Source
Drug Recall
External ID
D-0122-2025
Action Date
2024-12-18
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025
Quantity Affected: 55,032 bottles
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Distribution
Nationwide within the United States and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-18
Company
Canonsburg, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 105 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Viatris Inc has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Viatris Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Viatris Inc have FDA actions?
Viatris Inc has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0122-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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