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Recall Observatory FDA recall evidence

Drug 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.

D-1444-2014

July 17, 2014

Class III

Product summary

Firm
X-Gen Pharmaceuticals Inc.
Event
Event 68729
Status
Terminated
Classification
Class III
Quantity
8,356 vials
Official record key
drug-enforcement:D-1444-2014

Official wording

Reason: 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".

Code information: Lot: PLNB1412, Exp 12/15

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error