Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Recalls
- 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).
Lots: Lot #s VGC17040 & VGC17041, EXP 07/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ganciclovir: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 450 mg
- Approval
- ANDA ANDA205166
- On the market since
- Mar 18, 2016
- Package NDCs
31722-832-3131722-832-3231722-832-60- Official label
- DailyMed (National Library of Medicine), updated Jan 9, 2025
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