February 2023 FDA Recall Levothyroxine Sodium by Alvogen, Inc
D-0353-2023 - Sub-Potent Drug
This Class II drug recall was voluntarily initiated by Alvogen, Inc on February 6, 2023 for the product Levothyroxine Sodium. The FDA reported the reason for recall as sub-potent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0353-2023
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
02-06-2023
03-08-2023
21,276 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alvogen, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico.
03-18-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# HE02221, Exp. 05/2023
