Home / Recalls / Hikma Pharmaceuticals USA Inc. / D-0801-2020

D-0801-2020 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
January 29, 2020
Initiation Date
January 14, 2020
Termination Date
September 8, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4840 vials

Product Description

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

Reason for Recall

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1901113.1, Exp JUL 2021

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-0771-2021 Class III — Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only (August 5, 2021)