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 mg30-count bottleRx 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 #: MON17384Exp 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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