Hikma Pharmaceuticals USA Inc.: Drug Recall

Recall Details

Recall Number

D-0635-2024

Classification

Class I

Product Type

Drug

Recalling Firm

Hikma Pharmaceuticals USA Inc.

Status

Ongoing

Date Initiated

07/08/2024

Location

Cherry Hill, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

31,400 bags

Reason for Recall

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

Product Description

Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01

Distribution Pattern

OH and PR

Other Recalls by Hikma Pharmaceuticals USA Inc.

• Class II: Risk 07/22/2025
  Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
• Class II: Risk 03/12/2024
  The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
• Class II: Risk 05/11/2023
  Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
• Class II: Risk 12/16/2022
  Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
• Class II: Risk 07/11/2022
  Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

View all recalls by Hikma Pharmaceuticals USA Inc. →