chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Glenmark Pharmaceuticals Inc., USA
- Reason for Recall:
- CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Product Codes/Lot Numbers:
Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0159-2025
Related Recalls
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Failed Impurities/Degradation Specifications