Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Product description
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Lot numbers, UPCs & expiration codes
Lot#s: 17232222 and 17232237, Exp 10/31/2025
Where it was sold
Nationwide in the USA and PR
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-0309-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 11, 2025
- FDA report date
- Apr 9, 2025
- Quantity
- 8160 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0309-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95658
- Address
- 750 Corporate Dr
- Code information
- Lot#s: 17232222 and 17232237, Exp 10/31/2025
- Postal code
- 07430-2009
- Report date
- Apr 9, 2025
- Product type
- Drugs
- Recall number
- D-0309-2025
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 8160 bottles
- 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 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
- Distribution pattern
- Nationwide in the USA and PR
- Recall initiation date
- Mar 11, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 2, 2025