Reported Apr 23, 2025 · Ongoing
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606
Is this the product you have?
- ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only
- Packaged and Distributed byMajor Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
- Lot codes and dates
Lot#: N02114Exp 12/31/2025
- Amount recalled
- 133 cartons
Where it was sold
- Nationwide
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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