NDC 64661-650
EnBrace HR 16 ingredients capsule, delayed release pellets
On the label: JayMac Pharmaceuticals LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ocean Healthcare Pvt Ltd | Chengalpattu, India | Makes it | Problems found, fixed voluntarilyJun 14, 2024 · 1 inspection |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: All Lots distributed 02/23/2021 through 03/10/2021.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levomefolate Magnesium, Leucovorin, Folic Acid, Ferrous Cysteine Glycinate, Magn: every company that makes it
- Form
- capsule, delayed release pellets, oral
- Strength
- 16 ingredients
- Approval
- UNAPPROVED DRUG OTHER
- On the market since
- Aug 12, 2011
- Package NDCs
64661-650-30- Official label
- DailyMed (National Library of Medicine), updated Sep 11, 2026
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