Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity
The FDA is recalling Chlorpromazine Hydrochloride Tablets, 10 mg, due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above recommended limits. The affected lot was distributed nationwide.
What this means for you
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: This is an FDA Class II recall. The source text does not report any illnesses, hospitalizations, or injuries, only a manufacturing deviation with an impurity above recommended limits. The hazard is manufacturing-related rather than a known high-risk pathogen or structural defect.
Plain-English summary
Major Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets, USP, 10 mg, distributed nationwide. The recall affects 133 cartons of the product packaged in boxes of 100 tablets (10x10 configuration), with NDC 0904-7129-61. The specific lot number involved is N02114, with an expiration date of 12/31/2025.
The recall was initiated due to current good manufacturing practice (CGMP) deviations. Testing identified the presence of N-Nitroso-Desmethyl Chlorpromazine impurity in the product at levels above the recommended interim limit. This is a prescription medication indicated for oral use.
Patients currently taking this medication should consult their healthcare provider or pharmacist before discontinuing use or taking any action. Healthcare providers and patients should report any adverse events related to this product to the FDA's MedWatch program.
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
- impurity
- cgmp-deviation
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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