Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 5
Summary
The FDA issued a Class II for Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manuf by Alvogen, Inc. Reason: Sub-Potent Drug: Out of specification for assay at the 24 month interval..
Details
Source
Drug Recall
External ID
D-0353-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
Product Description
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Lot/Code Info: Lot # HE02221, Exp. 05/2023
Quantity Affected: 21,276 bottles
Reason for Recall
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Distribution
Nationwide and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-06
Company
Morristown, NJ
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 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alvogen, Inc has 4 FDA actions in our database, including 4 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 (Alvogen, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alvogen, Inc have FDA actions?
Alvogen, Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0353-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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