X-Gen Recalls Clonidine HCl Injection Due to Labeling Error
X-Gen Pharmaceuticals is recalling Clonidine HCl Injection vials because the side label incorrectly states the drug strength.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling 8,356 vials of Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL), 10 mL Single Dose Vial. The product is identified by Lot PLNB1412 and an expiration date of 12/15. The recall is due to a labeling error where the side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of the correct "Each mL contains 100 mcg Clonidine Hydrochloride."
The affected product is a prescription-only medication manufactured for X-Gen Pharmaceuticals Inc. in Big Flats, NY. The recall is distributed nationwide. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for this specific lot and expiration date. If the product is found, it should be returned to the distributor or the manufacturer for credit. Consumers should not use the product if they have questions regarding the label accuracy.
The recalled product
- Product
- CLONIDINE (CLONIDINE)
- Brand
- CLONIDINE
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 8,356
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: PLNB1412
- Exp 12/15
Distribution
Distributed nationwide across the United States.
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