FDAFDA · Food and drugs·Recall number D-0309-2025
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Published April 9, 2025 · Recall initiated: March 11, 2025
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: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Nationwide in the USA and PR
- UPC
- 0368462862018
- Lot
- Lot#s: 17232222 and 17232237, Exp 10/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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