Home / Recalls / Ingenus Pharmaceuticals Llc / D-0374-2022

D-0374-2022 Class II Terminated

Recalled by Ingenus Pharmaceuticals Llc — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
January 26, 2022
Initiation Date
January 10, 2022
Termination Date
August 15, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45,173 cans

Product Description

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.

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide in the USA

Code Information

a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.

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-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)