Alvogen, Inc: Drug Recall

Recall #D-0353-2023 · 02/06/2023

Class II: Risk

Recall Details

Recall Number: D-0353-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Alvogen, Inc
Status: Terminated
Date Initiated: 02/06/2023
Location: Morristown, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21,276 bottles

Reason for Recall

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

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.

Distribution Pattern

Nationwide and Puerto Rico.

Other Recalls by Alvogen, Inc

Class II: Risk 12/31/2025

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class I: Dangerous 01/31/2025

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II: Risk 02/26/2021

Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)

View all recalls by Alvogen, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.