Recalls / Class III
Class IIID-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.
- Brand name
- Clonidine
- Generic name
- Clonidine
- Active ingredient
- Clonidine Hydrochloride
- Route
- Epidural
- NDCs
- 39822-2000, 39822-2010
- FDA application
- ANDA203167
- Affected lot / code info
- Lot: PLNB1412, Exp 12/15
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".
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Drive, Horseheads, New York 14845-1014
Distribution
- Quantity
- 8,356 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-17
- FDA classified
- 2014-07-18
- Posted by FDA
- 2014-07-30
- Terminated
- 2015-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1444-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.