Recalls / Class III
Class IIID-1084-2019
Product
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, 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
- Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
Why it was recalled
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Dr, N/A, Horseheads, New York 14845-1014
Distribution
- Quantity
- 24,966 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-03-29
- FDA classified
- 2019-04-08
- Posted by FDA
- 2019-04-17
- Terminated
- 2021-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1084-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.