chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Reported: January 1, 2025 Initiated: December 11, 2024 #D-0159-2025
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Reason for Recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 3,888
- Distribution
- USA Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 3,888.
Why was this product recalled? ▼
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 1, 2025. Severity: Moderate. Recall number: D-0159-2025.
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