Home / Recalls / Ingenus Pharmaceuticals Llc / D-0146-2020

D-0146-2020 Class II Terminated

Recalled by Ingenus Pharmaceuticals Llc — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
October 23, 2019
Initiation Date
October 9, 2019
Termination Date
December 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16485 vials

Product Description

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

Reason for Recall

Crystallization: Presence of particulate matter identified as API crystallization

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020

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-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)