Reported Oct 3, 2018 · Ongoing

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

Hetero Labs Limited Unit V

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hetero Labs Limited Unit V · Unit V (SEZ Unit I in APIIC SEZ) · Jadcherla Mandal, Mahaboob Nagar · N/A

Is this the product you have?

    • Montelukast Sodium Tablets 10 mg
    • 30-count bottle
    • Rx Only
  • ByHetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India
  • Manfuactured forCamber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Lot codes and dates
    • Lot #: MON17384
    • Exp 12/19
Amount recalled
98016 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.