NDC 43598-405
Phytonadione Phytonadione 10 mg per 1 mL injection, emulsion
On the label: Dr. Reddy's Laboratories Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it and tests it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
Recalls
- Sep 14, 2022 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Lots: Lot # ACB101, Exp 03/2023 - Mar 16, 2020 · Class I · Dr. Reddy's Laboratories, Inc.
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Lots: Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phytonadione: every company that makes it
- Form
- injection, emulsion, intramuscular; intravenous; subcutaneous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA207719
- On the market since
- May 31, 2019
- Package NDCs
43598-405-1143598-405-16- Official label
- DailyMed (National Library of Medicine), updated May 30, 2019
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