Recalls / Class II
Class IID-0643-2025
Product
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 50268-162, 50268-163, 50268-164, 50268-165, 50268-166
- FDA application
- ANDA209755
- Affected lot / code info
- Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25
Why it was recalled
Presence of a foreign substance.
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 1512 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-08-25
- FDA classified
- 2025-09-11
- Posted by FDA
- 2025-09-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0643-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.