Jubilant Cadista Pharmaceuticals

45 FDA enforcement records linked to this company.

• 4832025-01-15

  Systems in place to comply with verification requirements

• 4832025-01-15

  Signature and checking of records -- 2 persons

• 4832025-01-15

  Identification of Persons Performing Significant Steps

• 4832025-01-15

  Rejected in-process materials not quarantined

• 4832025-01-15

  Records not made readily available to FDA

• recall — Class III2023-01-11

  Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

• recall — Class II2022-08-03

  Failed dissolution specifications.

• recall — Class II2022-08-03

  Failed Dissolution Specifications

• recall — Class III2022-04-13

  Subpotent

• recall — Class I2022-04-06

  Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

• recall — Class III2021-09-08

  Subpotent

• recall — Class II2021-04-21

  Failed Dissolution Specifications

• recall — Class III2021-03-10

  Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.

• recall — Class II2020-12-02

  Failed Tablet/Capsule Specification

• recall — Class III2020-11-11

  Subpotent