Recalls / Class II
Class IID-0649-2022
Product
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
- Brand name
- Paliperidone
- Generic name
- Paliperidone
- Active ingredient
- Paliperidone
- Route
- Oral
- NDCs
- 0904-6935, 0904-6936, 0904-6937
- FDA application
- ANDA205618
- Affected lot / code info
- Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17187 N Laurel Park Dr Ste 300, N/A, Livonia, Michigan 48152-2600
Distribution
- Quantity
- 174 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-02-28
- FDA classified
- 2022-03-09
- Posted by FDA
- 2022-03-16
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0649-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.