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.
Reported: July 30, 2014 Initiated: July 17, 2014 #D-1444-2014
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.
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".
Details
- Recalling Firm
- X-Gen Pharmaceuticals Inc.
- Units Affected
- 8,356 vials
- Distribution
- Nationwide
- Location
- Horseheads, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by X-Gen Pharmaceuticals Inc.. Units affected: 8,356 vials.
Why was this product 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".
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2014. Severity: Low. Recall number: D-1444-2014.
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