D-1084-2019 Class III Terminated
FDA drug recall D-1084-2019 was initiated by X-Gen Pharmaceuticals Inc. on March 29, 2019 and is designated Class III. Reason for recall: 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 Hydro… The recall status is terminated (terminated June 2, 2021). Affected quantity: 24,966 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 29, 2019
- Termination Date
- June 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,966 vials
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;