FDAFDA · Food and drugs·Recall number D-1444-2014
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
Published July 30, 2014 · Recall initiated: July 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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".
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- CLONIDINE
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- Lot: PLNB1412, Exp 12/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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