Reported Jul 30, 2014 · Terminated
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen…
X-Gen Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Drive · Horseheads, NY · 14845-1014
Is this the product you have?
- Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only
- Manufactured forX-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1
- Lot codes and dates
- Lot
PLNB1412Exp 12/15
- Lot
- Amount recalled
- 8,356 vials
Where it was sold
- Nationwide
Why it was recalled
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".
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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