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Class III: unlikely to cause harmTerminated

X-Gen Pharmaceuticals Clonidine HCl Injection Recall

Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, M…

X-Gen Pharmaceuticals Inc. · Horseheads, NY

Risk level
Class III
Reported by FDA
Jul 30, 2014
Recall ID
D-1444-2014
Check your lot numberHow we source this data

Summary

X-Gen Pharmaceuticals recalled Clonidine HCl Injection starting Jul 17, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1444-2014 on Jul 30, 2014. 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". Status: Terminated.

Why it was recalled

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".

Product description

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.

Lot numbers, UPCs & expiration codes

Lot: PLNB1412, Exp 12/15

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1444-2014
Classification
Class III
Status
Terminated
Recall initiated
Jul 17, 2014
FDA report date
Jul 30, 2014
Quantity
8,356 vials
Recall type
Voluntary: Firm initiated
Recalling firm
X-Gen Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-1444-2014, exactly as published.

Show all FDA fields
City
Horseheads
State
NY
Status
Terminated
Country
United States
Event ID
68729
Address
300 Daniel Zenker Drive
Code information
Lot: PLNB1412, Exp 12/15
Postal code
14845-1014
Report date
Jul 30, 2014
Product type
Drugs
Recall number
D-1444-2014
Classification
Class III
Recalling firm
X-Gen Pharmaceuticals Inc.
Product quantity
8,356 vials
Termination date
Oct 7, 2015
Reason for recall
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".
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Nationwide
Recall initiation date
Jul 17, 2014
Initial firm notification
E-Mail
Center classification date
Jul 18, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1444-2014, published Jul 30, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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