Chlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.
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 initiated due to manufacturing deviations resulting in impurity levels exceeding FDA limits. No illnesses or injuries have been reported. Per the rubric, this constitutes a 'risk-of-harm product where injury has not yet been reported,' warranting a score of 3.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Chlorpromazine Hydrochloride Tablets, USP, 25 mg in 100-count bottles. This recall affects lot number 17230133, which expires 12/31/2024, and was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing found that N-Nitroso-Desmethyl Chlorpromazine (NNDCI) impurity exceeded the FDA's recommended limit.
Patients or healthcare providers who may have received medication from this lot should verify the lot number with their pharmacy. Those with questions should contact their pharmacist or healthcare provider.
For more information about this recall, contact Glenmark Pharmaceuticals Inc. or visit the FDA's drug recall website.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- impurity-excess
- 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#: 17230133
- Exp 12/31/2024
UPCs (4)
- 0368462862018
- 0368462864012
- 0368462863015
- 0368462861011
Distribution
Distributed nationwide across the United States.
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