Reported Apr 16, 2025 · Ongoing
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles
- Manufactured byZydus Lifesciences Ltd., Baddi, India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
- Lot codes and dates
Lot #: Z400069Exp.: 12/31/2025
- Amount recalled
- 3144 bottles, pack size: 100's Count
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
This product could cause temporary or reversible health problems — stop using it.
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