Hikma Pharmaceuticals PLC

44 FDA enforcement records linked to this company.

• recall — Class II2026-05-06

  This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

• recall — Class II2025-08-06

  Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

• recall — Class I2024-08-28

  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)

• 4832024-06-12

  Procedures not in writing, fully followed

• 4832024-06-12

  Procedures for non-sterile drug products

• 4832024-06-12

  Scientifically sound laboratory controls

• recall — Class II2024-03-27

  The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

• 4832023-09-29

  Written record of investigation incomplete

• 4832023-09-29

  Validation lacking for sterile drug products

• recall — Class II2023-05-24

  Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

• recall — Class II2023-01-04

  Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

• recall — Class II2022-08-17

  Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

• recall — Class II2022-08-17

  Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

• recall — Class II2022-08-17

  Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

• recall — Class II2022-08-17

  Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.