Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one…
Reason Failed Dissolution Specifications; three month stability time point.
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