Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor, Nucleoside Analog Antiviral

Where is Ganciclovir made?

25 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 17 factories in India, the United States and Canada.

India 10United States 6Canada 1

Companies and their factories

Repackaged by

These companies buy Ganciclovir in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.

• American Health Packaging: 68084-965
• AvKARE, Inc.: 42291-973, 42291-972
• AvPAK: 50268-787
• Major Pharmaceuticals: 0904-6796

Recalls

• Dec 16, 2022 · Class II · Hikma Pharmaceuticals USA Inc.
  Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
• Nov 4, 2019 · Class II · Teva Pharmaceuticals USA, Inc.
  Presence of foreign substance: Brown/black particles found during stability testing.
• Feb 13, 2018 · Class II · Hetero Labs Limited Unit V
  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-0415-2018).

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.