Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Dec 6, 2013 · Class III · Fresenius Kabi USA, LLC
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Lots: Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14 - May 21, 2013 · Class III · Fresenius Kabi USA, LLC
Failed Impurities/Degradation Specification
Lots: Lot #: 6103883, Exp 10/2013
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Folic Acid: every company that makes it
- Form
- injection, solution, intramuscular; intravenous; subcutaneous
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA089202
- On the market since
- Sep 5, 2000
- Package NDCs
63323-184-10- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2024
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