FDAClass IIRecall started February 6, 2023

Levothyroxine Sodium Tablets 112 mcg Recall

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.

What is the FDA recall status?

The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.

How FDA enforcement data reports status

Why was Levothyroxine Sodium Tablets 112 mcg recalled?

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

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full 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.

Which lot codes, UPCs or models are affected?

Lot # HE02221, Exp. 05/2023

Agency record number
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.
Recalling firm
Alvogen, Inc
Quantity
21,276 bottles
Distribution
Nationwide and Puerto Rico.
Recall started
February 6, 2023
Report date
March 8, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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