NDC 68382-048
acyclovir 50 mg per 1 mL injection, solution
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- Feb 18, 2021 · Class I · Zydus Pharmaceuticals (USA) Inc
Crystallization: customer complaints for crystallization in finished product.
Lots: Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022 - Feb 18, 2021 · Class I · Zydus Pharmaceuticals (USA) Inc
Crystallization: customer complaints for crystallization in finished product.
Lots: Lot#: L000126, L000127, Exp 12/31/2021
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
- injection, solution, intravenous
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA206535
- On the market since
- Nov 27, 2018
- Package NDCs
68382-048-0168382-048-10- Official label
- DailyMed (National Library of Medicine), updated Nov 29, 2021
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