X-Gen Recalls Clonidine Injection Vials Due to Labeling Error
X-Gen Pharmaceuticals is recalling Clonidine HCL Injection vials because the side carton incorrectly lists the concentration as 500 mcg instead of 100 mcg per mL.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of or exposure to the product is not likely to cause adverse health consequences. The hazard is a minor labeling error regarding concentration.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling 24,966 vials of Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial. The recall is due to a labeling error where the side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
The affected product is distributed nationwide in the USA. The specific lots involved are PMXA1917 (Exp 09/2020), PMXA1937, and PMXA1938 (Exp 11/2020). The product is a prescription-only medication manufactured for X-Gen Pharmaceuticals in Big Flats, NY.
Healthcare providers and patients should verify the lot numbers and expiration dates of their Clonidine HCL Injection vials against the recalled list. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- CLONIDINE (CLONIDINE)
- Brand
- CLONIDINE
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 24,966
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 (5)
- Lots #: PMXA1917
- Exp 09/2020
- PMXA1937
- PMXA1938
- Exp 11/2020
Distribution
Distributed nationwide across the United States.
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