FDAClass IIFebruary 19, 2014

Levothyroxine Sodium Tablets recall: Subpotent

Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01

Why was Levothyroxine Sodium Tablets recalled?

Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

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

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14

Product
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
Recalling firm
Mylan Pharmaceuticals Inc.
Quantity
138,970 bottles
Distribution
Nationwide.
Recall date
February 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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