NDC 68462-863
Chlorpromazine Hydrochloride 50 mg tablet, film coated
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Mar 11, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Lots: Lot#s: 17232222 and 17232237, Exp 10/31/2025 - Dec 11, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Lots: Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025 - Dec 11, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Lots: Lot#: 17230133, Exp 12/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Chlorpromazine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA212144
- On the market since
- Mar 23, 2021
- Package NDCs
68462-863-0168462-863-10- Official label
- DailyMed (National Library of Medicine), updated Oct 13, 2023
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