PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: March 8, 2023 Initiated: February 6, 2023 #D-0353-2023

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.

Reason for Recall

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

Details

Recalling Firm
Alvogen, Inc
Units Affected
21,276 bottles
Distribution
Nationwide and Puerto Rico.
Location
Morristown, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Alvogen, Inc. Units affected: 21,276 bottles.
Why was this product recalled?
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2023. Severity: Moderate. Recall number: D-0353-2023.