Home › Prescription medicine › The Harvard Drug Group LLC dba Major…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indiana
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
The product
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Details
- Units affected
- 133 cartons
- Recall date
- April 14, 2025
- Brand
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Nationwide USA
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indiana”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine