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Class II · ModerateRecall completed

Valganciclovir

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

Does this affect you?
Check your lot numberLot #s VGC17040 & VGC17041, EXP 07/2019
Where it was soldNJ and then distributed Nationwide 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: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-[redacted-phone]).

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 nameVALGANCICLOVIR
Generic nameVALGANCICLOVIR
Active ingredient(s)VALGANCICLOVIR HYDROCHLORIDE
Distributed by / forCamber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India
NDC31722-832-60
Show the full FDA record
Full product labelValganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
Recalling firmHetero Labs Limited Unit V
DistributionNJ and then distributed Nationwide in the USA
Quantity1764 60-count bottles
Recall initiated2018-02-13
Report date2018-03-21
Recall completed2021-02-18
Recall numberD-0601-2018
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.