Home / Recalls / Ingenus Pharmaceuticals Llc / D-0010-2023

D-0010-2023 Class II

Recalled by Ingenus Pharmaceuticals Llc — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
October 26, 2022
Initiation Date
September 30, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6176 bottles

Product Description

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

Reason for Recall

Out of specification for related substances (impurities).

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023

Other recalls by Ingenus Pharmaceuticals Llc

  • D-0374-2022 Class II — Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), a (January 10, 2022)
  • D-0146-2020 Class II — Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Via (October 9, 2019)
  • D-1058-2019 Class III — Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only (March 18, 2019)
  • D-0890-2018 Class II — Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single (June 8, 2018)
  • D-0891-2018 Class II — Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single (June 8, 2018)