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
Reported: March 16, 2022 Initiated: February 28, 2022 #D-0649-2022
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
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 174 cartons
- Distribution
- Nationwide within the United States
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group. Units affected: 174 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 16, 2022. Severity: Moderate. Recall number: D-0649-2022.
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