Prescription drug Chlorpromazine Hydrochloride tablets recalled for nitrosamine impurity
Zydus Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets nationwide due to manufacturing deviations resulting in N-Nitroso Desmethyl Chlorpromazine exceeding FDA acceptable intake limits. Affected lots are Z403011 and Z407335.
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 involving a known carcinogenic impurity exceeding acceptable limits. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for Score 3.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Chlorpromazine Hydrochloride Tablets, USP, 10 mg (NDC 16714-047-01) due to manufacturing deviations related to N-Nitroso Desmethyl Chlorpromazine levels exceeding the FDA's recommended acceptable intake limit. The affected lots are Z403011 (expiration date 30-04-26) and Z407335 (expiration date 30-11-26).
Chlorpromazine Hydrochloride is a prescription antipsychotic medication. The recalled product has been distributed nationwide in the USA. N-Nitroso Desmethyl Chlorpromazine is a potential impurity of concern in pharmaceutical products.
Patients currently taking the recalled medication should consult their healthcare provider before discontinuing use. Healthcare providers should stop dispensing affected lot numbers. Patients with bottles matching the recalled lot numbers should return them to their pharmacy or follow their healthcare provider's instructions regarding continuation of therapy.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- 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 (4)
- Lot#: Z403011
- Exp Date 30-04-26
- Z407335
- Exp Date 30-11-26
Distribution
Distributed nationwide across the United States.
Related recalls
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