Chlorpromazine Hydrochloride Tablets Recalled for Manufacturing Defect Impurity
Zydus Pharmaceuticals recalls Chlorpromazine Hydrochloride 100 mg tablets nationwide due to manufacturing deviations resulting in N-Nitroso Desmethyl Chlorpromazine impurity above acceptable limits.
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: FDA Class II recall for risk-of-harm product. N-Nitroso compounds are potential carcinogens; exceeding the recommended acceptable intake limit presents a potential health risk. No illnesses or injuries have been reported.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Chlorpromazine Hydrochloride Tablets, USP, 100 mg in 100-count bottles (NDC 16714-050-01) distributed nationwide in the United States. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit.
Affected lots are: Lot Z305456 (Exp 31-10-25), Lot Z401156 (Exp 28-02-26), and Lot Z407306 (Exp 30-11-26). The product was manufactured by Zydus Lifesciences Ltd. in Baddi, India and manufactured for Northstar Rx LLC in Memphis, Tennessee.
Patients currently taking this medication should contact their healthcare provider or pharmacist. Do not stop taking the medication without medical guidance. Pharmacy staff and patients should verify lot numbers against the affected batches before dispensing or taking the medication.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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 (6)
- Lot #: Z305456
- Exp Date 31-10-25
- Z401156
- Exp Date 28-02-26
- Z407306
- Exp Date 30-11-26
Distribution
Distributed nationwide across the United States.
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