NDC 53002-0270
Acyclovir 800 mg tablet
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-778.
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 |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Apr 27, 2017 · Class III · Hetero USA Inc
Presence of Foreign Substance: human hair melded into tablet.
Lots: Lot # ACY16075 Exp. 09/2018
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
- Strength
- 800 mg
- Approval
- ANDA ANDA203834
- On the market since
- Nov 29, 2013
- Package NDCs
53002-0270-053002-0270-153002-0270-253002-0270-353002-0270-453002-0270-553002-0270-6- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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