Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
Recalls
- May 2, 2014 · Class II · Fresenius Kabi USA, LLC
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Lots: Lot # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005… - May 2, 2014 · Class II · Fresenius Kabi USA, LLC
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Lots: Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phenytoin: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA078052
- On the market since
- Dec 14, 2009
- Package NDCs
63323-403-0163323-403-0263323-403-0463323-403-10- Official label
- DailyMed (National Library of Medicine), updated Mar 31, 2023
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