FDA-Drug2022-03-16Class II

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

The Harvard Drug Group
Hazard

Failed Dissolution Specifications

Sold states
Nationwide within the United States
Affected count
174 cartons
Manufactured in
17187 N Laurel Park Dr Ste 300, N/A, Livonia, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2022

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