Drug recall D-1444-2014
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.
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".
Lots and codes
Lot: PLNB1412, Exp 12/15
Recall details
- Recalling firm
- X-Gen Pharmaceuticals Inc., Horseheads, NY
- Quantity
- 8,356 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 17, 2014
- Terminated
- October 7, 2015
Related products
- Clonidine – drug information
- NDC 39822-2000 Clonidine · Clonidine Hydrochloride 100 ug/mL · XGen Pharmaceuticals DJB, Inc.
- NDC 39822-2010 Clonidine · Clonidine Hydrochloride 500 ug/mL · XGen Pharmaceuticals DJB, Inc.