Reported Apr 17, 2019 · Terminated
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen…
X-Gen Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Dr · Horseheads, NY · 14845-1014
Is this the product you have?
- Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only
- Manufactured forX-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1
- Lot codes and dates
Lots #: PMXA1917Exp 09/2020PMXA1937PMXA1938Exp 11/2020
- Amount recalled
- 24,966 vials
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new X-Gen Pharmaceuticals Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.