Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: N02114, Exp 12/31/2025
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0366-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 14, 2025
- FDA report date
- Apr 23, 2025
- Quantity
- 133 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0366-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96679
- Address
- 341 Mason Rd
- Code information
- Lot#: N02114, Exp 12/31/2025
- Postal code
- 37086-3606
- Report date
- Apr 23, 2025
- Product type
- Drugs
- Recall number
- D-0366-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 133 cartons
- Reason for recall
- CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Apr 14, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 16, 2025