Class II · Moderate risk Terminated
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun…
Reason Failed Dissolution Specifications
Is Paliperidone recalled?
5 FDA recalls mention Paliperidone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Paliperidone.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC…
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle…
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I · High risk Terminated
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one…
Class II · Moderate risk Terminated
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC…
Reason Failed Dissolution Specifications; three month stability time point.
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