Class II · Moderate risk Terminated
RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Risperidone recalled?
6 FDA recalls mention Risperidone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Risperidone.
Class II · Moderate risk Terminated
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class III · Low risk Terminated
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad…
Reason Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Class III · Low risk Terminated
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9…
Reason Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class II · Moderate risk Terminated
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560…
Reason Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
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