FDA Drug recall D-0309-2025
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Ma…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Ma… by Glenmark Pharmaceuticals Usa, citing CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0309-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-11 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
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
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Identifiers
| ndc | 68462-861-01 |
|---|---|
| ndc | 68462-861-10 |
| ndc | 68462-862-01 |
| ndc | 68462-862-10 |
| ndc | 68462-863-01 |
| ndc | 68462-863-10 |
| ndc | 68462-864-01 |
| ndc | 68462-864-10 |
| ndc | 68462-865-01 |
| ndc | 68462-865-10 |
| code_info | Lot#s: 17232222 and 17232237, Exp 10/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0309-2025%22
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