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Class II · ModerateRecall completed

Entecavir

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # ENT17008, Exp 01/2019
Where it was soldNJ
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCamber Pharmaceuticals, Inc.
Brand nameENTECAVIR
Generic nameENTECAVIR
Active ingredient(s)ENTECAVIR ANHYDROUS
Distributed by / forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India
NDC31722-833-30
Show the full FDA record
Full product labelEntecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
Recalling firmHetero USA Inc
DistributionNJ
Quantity5664 bottles
Recall initiated2017-07-20
Report date2017-08-23
Recall completed2019-02-27
Recall numberD-1095-2017
ClassificationClass II
FDA statusTerminated
Origin on filePiscataway NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.