Home / Recalls / Ingenus Pharmaceuticals Llc / D-1058-2019

D-1058-2019 Class III Terminated

Recalled by Ingenus Pharmaceuticals Llc — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
April 3, 2019
Initiation Date
March 18, 2019
Termination Date
March 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,435 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico.

Code Information

Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020

Other recalls by Ingenus Pharmaceuticals Llc

  • D-0010-2023 Class II — Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for (September 30, 2022)
  • 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-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)