FDA-Drug2018-10-31Class II
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Teva Pharmaceuticals USA
Hazard
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Sold states
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Affected count
3,785 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0097-2019Don't want to check this manually?
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