Orlando, FL, United States
Ingenus Pharmaceuticals Llc recalls
5 recalls recorded since 2018, most recently on 30 September 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Completed Class II Drugs
- Recall started
- 30 September 2022
- Reason
- Out of specification for related substances (impurities).
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0010-2023
- 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
Terminated Class II Drugs
- Recall started
- 10 January 2022
- Terminated
- 15 August 2023
- Reason
- CGMP Deviations
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0374-2022
- 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.
Terminated Class II Drugs
- Recall started
- 9 October 2019
- Terminated
- 1 December 2020
- Reason
- Crystallization: Presence of particulate matter identified as API crystallization
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0146-2020
- 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
Terminated Class III Drugs
- Recall started
- 18 March 2019
- Terminated
- 6 March 2020
- Reason
- Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
- Distribution
- Nationwide in the USA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1058-2019
- 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.
Terminated Class II Drugs
- Recall started
- 8 June 2018
- Terminated
- 1 May 2019
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0890-2018, D-0891-2018
- 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, Gmb
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.