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Ingenus Pharmaceuticals

6 recalls •

• Categories: Prescription Drugs

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7

Class I - Dangerous

Out of specification for related substances (impurities).

Sep 30, 2022 Prescription Drugs Nationwide View Details →

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.

Class I - Dangerous

CGMP Deviations

Jan 10, 2022 Prescription Drugs Nationwide View Details →

Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839

Class I - Dangerous

Crystallization: Presence of particulate matter identified as API crystallization

Oct 9, 2019 Prescription Drugs Nationwide View Details →

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.

Class I - Dangerous

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

Mar 18, 2019 Prescription Drugs Nationwide View Details →

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.

Class I - Dangerous

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

Jun 8, 2018 Prescription Drugs Nationwide View Details →

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.

Class I - Dangerous

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

Jun 8, 2018 Prescription Drugs Nationwide View Details →