Chlorpromazine Hydrochloride tablets recalled for excess chemical impurity
Zydus Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets (10 mg) due to elevated levels of N-Nitroso-Desmethyl Chlorpromazine impurity from manufacturing deviations.
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 FDA Class II recall involves a chemical impurity (N-Nitroso-Desmethyl Chlorpromazine) at levels above recommended limits. No illnesses or injuries have been reported. The hazard is present but unrealized, placing it in the "risk-of-harm products where injury has not yet been reported" category per the rubric.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Chlorpromazine Hydrochloride Tablets, USP 10 mg due to manufacturing deviations that resulted in elevated levels of N-Nitroso-Desmethyl Chlorpromazine impurity exceeding the recommended interim limit.
The affected product is packaged in bottles of 100 tablets under NDC 70710-1129-1, with lot number Z400069 and expiration date 12/31/2025. Approximately 3,144 bottles have been distributed nationwide.
No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare providers should not use the affected product. Patients should consult their healthcare provider for guidance.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Medication
- Hazard
- nitrosamine-impurity
- manufacturing-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 #: Z400069
- Exp.: 12/31/2025
UPCs (3)
- 0370710112912
- 0370710113216
- 0370710113018
Distribution
Distributed nationwide across the United States.
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