Class III
Terminated
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.
- Company
- X-Gen Pharmaceuticals Inc.
- Recall Initiated
- July 17, 2014
- Posted
- July 30, 2014
- Recall Number
- D-1444-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,356 vials
- Firm Location
- Horseheads, NY, United States
Reason for Recall
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".
Distribution
Nationwide
Lot / Code Info
Lot: PLNB1412, Exp 12/15
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