Home / Recalls / Hikma Pharmaceuticals USA Inc. / D-0771-2021

D-0771-2021 Class III Terminated

Recalled by Hikma Pharmaceuticals USA Inc. — Cherry Hill, NJ

Recall Details

Product Type
Drugs
Report Date
September 1, 2021
Initiation Date
August 5, 2021
Termination Date
June 8, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,152 vials

Product Description

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

Reason for Recall

Labeling: Not elsewhere classified: Mislabeling

Distribution Pattern

USA nationwide

Code Information

BL0018

Other recalls by Hikma Pharmaceuticals USA Inc.

  • D-0551-2025 Class II — Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured (July 22, 2025)
  • D-0635-2024 Class I — Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags (July 8, 2024)
  • D-0392-2024 Class II — Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx (March 12, 2024)
  • D-0574-2023 Class II — Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x (May 11, 2023)
  • D-0090-2023 Class II — Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, R (December 16, 2022)
  • D-1308-2022 Class II — Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per ca (July 11, 2022)
  • D-1307-2022 Class II — Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manu (July 11, 2022)
  • D-1309-2022 Class II — Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novap (July 11, 2022)
  • D-1310-2022 Class II — Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novap (July 11, 2022)
  • D-0169-2021 Class II — Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx (December 7, 2020)