Reported Oct 3, 2018 · Terminated
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally,…
Hetero Labs Limited Unit V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 bottles, Rx Only
- ByHetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India
- Manufactured forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30
- Lot codes and dates
Lot #: MON17355Exp 12/19
- Amount recalled
- 98,016 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
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
This product could cause temporary or reversible health problems — stop using it.
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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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