NDC 70710-1132
Chlorpromazine hydrochloride 100 mg tablet, film coated
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Recalls
- Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z305060, Z305061, Exp Date 31-08-25; Z306323, Exp Date 30-11-25; Z401153, Exp Date 28-02-26; Z403015, Z403016, Exp Date 30-04-26; Z405591, Exp Date 30-09-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26 - Apr 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Lots: Lot #: Z400069, Exp.: 12/31/2025
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
- 100 mg
- Approval
- ANDA ANDA213368
- On the market since
- Jan 27, 2020
- Package NDCs
70710-1132-170710-1132-270710-1132-4- Official label
- DailyMed (National Library of Medicine), updated Aug 12, 2024
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