FDAClass IOctober 3, 2018

Montelukast Sodium Tablets 10 mg recall: Labeling Error

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301…

Why was Montelukast Sodium Tablets 10 mg recalled?

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 #: MON17384, Exp 12/19

Product
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301…
Recalling firm
Hetero Labs Limited Unit V
Quantity
98016 bottles
Distribution
U.S.A. Nationwide
Recall date
October 3, 2018
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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