NDC 72189-051
Valacyclovir 1 g tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-705.
Where the pills inside were 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 |
| Hetero Labs Limited | Hobli Vemagal Kolar, India | Makes it | No problems foundJan 31, 2025 · 1 inspection |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
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 # VLC17027 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
- Acyclovir: every company that makes it
- Form
- tablet, film coated
- Strength
- 1 g
- Approval
- ANDA ANDA203047
- On the market since
- Jun 17, 2020
- Package NDCs
72189-051-2172189-051-30- Official label
- DailyMed (National Library of Medicine), updated Jun 29, 2023
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