drugs Class III Updated 2014-07-30

X-Gen Pharmaceuticals Inc. recalls Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL S

Recalled Product

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.


Hazard / Issue

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".

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: PLNB1412, Exp 12/15
View official government recall

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