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Jubilant Cadista Pharmaceuticals, Inc.

Jubilant Cadista Pharmaceuticals, Inc. Recalls

All product recalls associated with Jubilant Cadista Pharmaceuticals, Inc..

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Recall Summary

Total Recalls

31

Past Year

0

Class I (Serious)

2

Most Recent

Dec 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 31 recalls

Prochlorperazine Tablets (Jubilant) – Subpotent Drug (2022)

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

FDADec 27, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Irbesartan Tablets (Jubilant Cadista) – Dissolution Failure (2022)

Failed Dissolution Specifications

Class IIModerate

FDAJul 18, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Irbesartan Tablets (Jubilant Cadista) – Dissolution Failure (2022)

Failed dissolution specifications.

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Moderate

FDAJul 18, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Methylprednisolone Tablets (Jubilant Cadista) – Subpotent Medication (2022)

Subpotent

FDAApr 1, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Meclizine Tablets (Jubilant Cadista) – Labeling Error (2022)

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

FDAMar 8, 2022AR, FL, IN +3 more• Jubilant Cadista Pharmaceuticals, Inc.

Donepezil HCL Tablets (Jubilant Cadista) – Subpotent Medication (2021)

Subpotent

FDAAug 20, 2021Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Itraconazole Capsules (Jubilant Cadista) - Failed Dissolution (2021)

Failed Dissolution Specifications

Class IIModerate

FDAApr 1, 2021Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Methylprednisolone Tablets (Jubilant Cadista) – Illegible Label (2021)

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

FDAFeb 19, 2021Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Clomipramine Capsules (Jubilant) – Specification Failure (2020)

Failed Tablet/Capsule Specification

Class IIModerate

FDANov 6, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Olanzapine ODT (Jubilant) – Subpotent Medication (2020)

Subpotent

FDAOct 26, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Lamotrigine Tablets (Jubilant Cadista) – Foreign Substance Risk (2020)

Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.

FDAMay 26, 2020TN• Jubilant Cadista Pharmaceuticals, Inc.

Pantoprazole Tablets (Jubilant Cadista) – tablet discoloration (2020)

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

Class IIModerate

FDAMar 11, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Amantadine Tablets (Jubilant Cadista) – Foreign Substance (2019)

Presence of Foreign Substance: Presence of a foreign object in a single tablet.

Class IIModerate

FDADec 2, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Pantoprazole Tablets (Jubilant) - tablet discoloration (2019)

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

Class IIModerate

FDASep 4, 2019MS, OH, RI +2 more• Jubilant Cadista Pharmaceuticals, Inc.

Drospirenone Ethinyl Estradiol Tablets (Jubilant Cadista) – Failed Dissolution (2019)

Failed dissolution specifications : failed results at the 3-month stability time point.

FDAJul 9, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Pantoprazole Sodium Tablets (Jubilant Cadista) – Tablet Discoloration (2019)

Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.

Class IIModerate

FDAMar 29, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Bupropion Extended-Release Tablets (Jubilant) – Dissolution Failure (2019)

Failed Dissolution Specifications; 9-monthstability timepoint

FDAFeb 28, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Pantoprazole Tablets (Jubilant Cadista) – Tablet Discoloration (2018)

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Class IIModerate

FDAOct 2, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

MethylPREDNISolone Tablets (Jubilant Cadista) – Stability Failure (2018)

Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.

FDAAug 27, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.