Ingenus Pharmaceuticals recalls
FDA enforcement reports naming Ingenus Pharmaceuticals Llc as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Oct 26, 2022
- Oct 26, 2022Flunisolide Nasal Solution, USP 0Drug · Ingenus Pharmaceuticals LlcOut of specification for related substances (impurities).Class II
- Jan 26, 2022Clobetasol Propionate Foam, 0Drug · Ingenus Pharmaceuticals LlcCGMP DeviationsClass II
- Oct 23, 2019Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 5…Drug · Ingenus Pharmaceuticals LlcCrystallization: Presence of particulate matter identified as API crystallizationClass II
- Apr 3, 2019Diclofenac Sodium Topical Solution, 1Drug · Ingenus Pharmaceuticals LlcDefective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.Class III
- Jul 11, 2018Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose V…Drug · Ingenus Pharmaceuticals LlcSuperpotent Drug: High out of specification assay value results for potency.Class II
- Jul 11, 2018Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vi…Drug · Ingenus Pharmaceuticals LlcSuperpotent Drug: High out of specification assay value results for potency.Class II