Recalls / Class II
Class IID-0366-2025
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
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 0904-7132, 0904-7129, 0904-7130, 0904-7131, 0904-7133
- FDA application
- ANDA213368
- Affected lot / code info
- Lot#: N02114, Exp 12/31/2025
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 133 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2025-04-14
- FDA classified
- 2025-04-16
- Posted by FDA
- 2025-04-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0366-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.