Ingenus Pharmaceuticals Llc Recalls

All product recalls associated with Ingenus Pharmaceuticals Llc.

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Recall Summary

Total Recalls

6

Past Year

0

Class I (Serious)

0

Most Recent

Sep 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 1–6 of 6 recalls

Flunisolide Nasal Solution (Ingenus) – substance impurity (2022)

Out of specification for related substances (impurities).

Class IIModerate

FDASep 30, 2022Nationwide• Ingenus Pharmaceuticals Llc

Clobetasol Propionate Foam (Ingenus) – CGMP Issues (2022)

CGMP Deviations

Class IIModerate

FDAJan 10, 2022Nationwide• Ingenus Pharmaceuticals Llc

Leucovorin Calcium Injection (Ingenus) – Crystallization Risk (2019)

Crystallization: Presence of particulate matter identified as API crystallization

Class IIModerate

FDAOct 9, 2019Nationwide• Ingenus Pharmaceuticals Llc

Diclofenac Sodium Solution (Ingenus) – Leaking Bottles (2019)

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

Class IIILow

FDAMar 18, 2019Nationwide• Ingenus Pharmaceuticals Llc

Irinotecan Hydrochloride Injection (Ingenus) – High Potency Risk (2018)

Superpotent Drug: High out of specification assay value results for potency.

Class IIModerate

FDAJun 8, 2018Nationwide• Ingenus Pharmaceuticals Llc

Irinotecan Hydrochloride Injection (Ingenus) – High Potency Risk (2018)

Superpotent Drug: High out of specification assay value results for potency.

Class IIModerate

FDAJun 8, 2018Nationwide• Ingenus Pharmaceuticals Llc

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Ingenus Pharmaceuticals Llc Recalls

Recall Summary

Flunisolide Nasal Solution (Ingenus) – substance impurity (2022)

Clobetasol Propionate Foam (Ingenus) – CGMP Issues (2022)

Leucovorin Calcium Injection (Ingenus) – Crystallization Risk (2019)

Diclofenac Sodium Solution (Ingenus) – Leaking Bottles (2019)

Irinotecan Hydrochloride Injection (Ingenus) – High Potency Risk (2018)

Irinotecan Hydrochloride Injection (Ingenus) – High Potency Risk (2018)