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Class II · ModerateRecall completed

Famciclovir

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

Does this affect you?
Check your lot numberLot # FMC17039, Exp 07/2019.
Where it was soldNationwide in the USA.
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

Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

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 nameFAMCICLOVIR
Generic nameFAMCICLOVIR
Active ingredient(s)FAMCICLOVIR
Distributed by / forCamber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India
NDC31722-708-30
Show the full FDA record
Full product labelFamciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Recalling firmHetero Labs Limited Unit V
DistributionNationwide in the USA.
Quantity8,436 bottles
Recall initiated2017-12-22
Report date2018-02-21
Recall completed2020-02-05
Recall numberD-0415-2018
ClassificationClass II
FDA statusTerminated
Origin on fileJadcherla Mandal, Mahaboob Nagar India

Related

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.