Ingenus Pharmaceuticals recalls
Ingenus Pharmaceuticals appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2022-10-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2018-07-11 to 2022-10-26 |
| By agency | FDA Drug (6) |
| By classification | Class II (5), Class III (1) |
| By status | terminated (5), completed (1) |
| Distribution named in notices | US |
Recalls
- Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408
FDA Drug · Class II · 2022-10-26 · Ingenus Pharmaceuticals
Reason: Out of specification for related substances (impurities). - 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 f…
FDA Drug · Class II · 2022-01-26 · Ingenus Pharmaceuticals
Reason: CGMP Deviations - 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. Or…
FDA Drug · Class II · 2019-10-23 · Ingenus Pharmaceuticals
Reason: Crystallization: Presence of particulate matter identified as API crystallization - Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando,…
FDA Drug · Class III · 2019-04-03 · Ingenus Pharmaceuticals
Reason: Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking. - Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceutic…
FDA Drug · Class II · 2018-07-11 · Ingenus Pharmaceuticals
Reason: Superpotent Drug: High out of specification assay value results for potency. - Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuti…
FDA Drug · Class II · 2018-07-11 · Ingenus Pharmaceuticals
Reason: Superpotent Drug: High out of specification assay value results for potency.