Hikma Injectables USA Inc

4 FDA enforcement actions

4 Total Recalls

1 Class I

2 Class II

1 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 12/19/2024 drug

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II: Risk 12/19/2024 drug

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class III: Low Risk 04/30/2024 drug

Labeling: Wrong Barcode
Class I: Dangerous 04/29/2024 drug

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.