D-0649-2022 Class II Terminated
FDA drug recall D-0649-2022 was initiated by The Harvard Drug Group on February 28, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated June 8, 2023). Affected quantity: 174 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 16, 2022
- Initiation Date
- February 28, 2022
- Termination Date
- June 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174 cartons
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022