FDA recall D-0353-2023

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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2023-02-06

Report date

2023-03-08

Termination date

2024-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morristown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2023