Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Vitae Enim Vitae Scientific, Inc. | San Diego, CA, United States | Makes it | Problems found, fixed voluntarilyJan 7, 2025 · 5 inspections, 2 with FDA action |
Recalls
- Mar 14, 2022 · Class II · Vitae Enim Vitae Scientific, Inc.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lots: Lot #: a) 20VPSI007, Exp 3/31/2022; 20VPSI015, Exp 5/30/2022; 20VPSI018, Exp 6/1/2022; 20VPSI032, Exp 11/30/2022; 21VPSI002, 21VPSI003, Exp 1/31/2023; 21VPSI006, Exp 3/31/2023; 21VPSI012, 21VPSI020, Exp 5/31/2023; 21VPSI035, Exp 7/31/2023; 21VPSI037, 21VPSI038, Exp 8/31/2023; 21VPSI043, 21VPSI044, … - Mar 14, 2022 · Class II · Vitae Enim Vitae Scientific, Inc.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lots: Lot # a) 20VPSI011, Exp. 4/30/2022; 20VPSI014, Exp. 5/31/2022; 20VPSI020, 20VPSI022, 20VPSI023, Exp. 7/31/2022; 21VPSI007, Exp. 3/31/2023; 21VPSI013, Exp. 5/31/2023; 21VPSI027, Exp. 6/30/2023; 21VPSI039, Exp. 8/31/2023; 21VPSI042, Exp. 10/31/2023; 21VPSI049, Exp. 11/30/2023; 21VPSI052, Exp. 12/31/2…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phenobarbital: every company that makes it
- Form
- injection, intramuscular
- Strength
- 130 mg per 1 mL
- Approval
- UNAPPROVED DRUG OTHER
- On the market since
- Feb 5, 2020
- Package NDCs
42494-416-0342494-416-25- Official label
- DailyMed (National Library of Medicine), updated Jun 4, 2025
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