NDC 39822-2000
Clonidine 100 ug per 1 mL injection, solution
On the label: XGen Pharmaceuticals DJB, Inc..
Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants XGen Pharmaceuticals DJB, Inc. names for other drugs.
Recalls
- Mar 29, 2019 · Class III · X-Gen Pharmaceuticals Inc.
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Lots: Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020; - Jul 17, 2014 · Class III · X-Gen Pharmaceuticals Inc.
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Lots: Lot: PLNB1412, Exp 12/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clonidine: every company that makes it
- Form
- injection, solution, epidural
- Strength
- 100 ug per 1 mL
- Approval
- ANDA ANDA203167
- On the market since
- Oct 29, 2013
- Package NDCs
39822-2000-1- Official label
- DailyMed (National Library of Medicine), updated Jan 30, 2024
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