Chlorpromazine tablets recalled for impurity exceeding recommended limits
The FDA is recalling Chlorpromazine Hydrochloride tablets due to a manufacturing quality issue involving an impurity that exceeds recommended limits. Patients taking this medication should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing quality deviation where an impurity exceeds a recommended safety limit in a pharmaceutical product. No illnesses or injuries have been reported. This represents a risk-of-harm product situation where the potential hazard has not yet resulted in confirmed patient harm.
Plain-English summary
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories is recalling 133 cartons of Chlorpromazine Hydrochloride Tablets, USP 10 mg (NDC 0904-7129-61, Lot N02114, expiring 12/31/2025) distributed nationwide in the United States.
The recall is due to a manufacturing quality deviation: the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Patients currently taking this medication should not stop taking it without consulting their healthcare provider. Those with affected lot numbers should contact their pharmacist or healthcare provider to determine if they have received affected product and to discuss appropriate next steps.
For additional information, patients and healthcare providers can contact Major Pharmaceuticals or refer to the FDA's Drug Recalls database.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Prescription Tablet
- Hazard
- manufacturing-defect
- chemical-impurity
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#: N02114
- Exp 12/31/2025
Distribution
Distributed nationwide across the United States.
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