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
Reported: April 9, 2025 Initiated: March 11, 2025 #D-0309-2025
Product Description
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
Reason for Recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 8160 bottles
- Distribution
- Nationwide in the USA and PR
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 8160 bottles.
Why was this product recalled? ▼
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 9, 2025. Severity: Moderate. Recall number: D-0309-2025.
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