FDAFDA · Food and drugs·Recall number D-0159-2025
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Published January 1, 2025 · Recall initiated: December 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- USA Nationwide
- UPC
- 0368462862018
- Lot
- Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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