Clonidine Hydrochloride 0.3 mg Tablets Recalled for Strength Mix-up
UNICHEM PHARMACEUTICALS is recalling Clonidine Hydrochloride Tablets labeled 0.3 mg that contain 0.2 mg tablets instead. The recall affects 18,960 bottles (Lot # GCLH22005) distributed nationwide.
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: FDA Class III recall with no reported illnesses or injuries. While the strength mix-up creates potential risk of incorrect dosing for a prescription medication, the hazard remains theoretical with no confirmed patient harm.
Plain-English summary
UNICHEM PHARMACEUTICALS USA INC is recalling Clonidine Hydrochloride Tablets, USP 0.3 mg strength due to a product mix-up. Bottles labeled as containing 0.3 mg tablets actually contain 0.2 mg tablets instead.
The affected product is a prescription medication. Because the tablets are a different strength than labeled, patients taking the medication may not receive the intended dose. This strength discrepancy could affect the medication's therapeutic effectiveness.
The recall involves approximately 18,960 bottles of 100-count bottles with Lot # GCLH22005, expiration date 02/29/2024, distributed nationwide in the United States. Consumers with questions should contact their pharmacy or healthcare provider.
The recalled product
- Product
- CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
- Brand
- CLONIDINE HYDROCHLORIDE
- Manufacturer
- UNICHEM PHARMACEUTICALS USA INC
- Category
- Drug
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 # GCLH22005
- exp. date 02/29/2024
UPCs (4)
- 0329300137019
- 0329300136012
- 0329300135015
- 0329300468014
Distribution
Distributed nationwide across the United States.
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