FDA Drug recall D-1444-2014
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Fla…
- FDA Drug
- Class III
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class III recall of Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Fla… by X Gen Pharmaceuticals, citing 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 1….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1444-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-17 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | X Gen Pharmaceuticals |
| Distribution | US |
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
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".
Identifiers
| ndc | 39822-2000-1 |
|---|---|
| ndc | 39822-2010-1 |
| code_info | Lot: PLNB1412, Exp 12/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1444-2014%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.