FDA Drug recall D-1084-2019
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, N…
- FDA Drug
- Class III
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class III recall of Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, N… by X Gen Pharmaceuticals, citing labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "10….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1084-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-29 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | X Gen Pharmaceuticals |
| Distribution | US |
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.
Reason
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.
Identifiers
| ndc | 39822-2000-1 |
|---|---|
| ndc | 39822-2010-1 |
| code_info | Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1084-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.