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D-0890-2018 Class II Terminated

Recalled by Ingenus Pharmaceuticals Llc — Orlando, FL

FDA drug recall D-0890-2018 was initiated by Ingenus Pharmaceuticals Llc on June 8, 2018 and is designated Class II. Reason for recall: Superpotent Drug: High out of specification assay value results for potency. The recall status is terminated (terminated May 1, 2019). Affected quantity: 34964 vials.

Recall Details

Product Type
Drugs
Report Date
July 11, 2018
Initiation Date
June 8, 2018
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34964 vials

Product Description

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, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.

Reason for Recall

Superpotent Drug: High out of specification assay value results for potency.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19

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-1058-2019 Class III — Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only (March 18, 2019)
  • D-0891-2018 Class II — Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single (June 8, 2018)

FDA data resources