D-0174-2025 Class II Terminated
FDA drug recall D-0174-2025 was initiated by Hikma Injectables USA Inc on December 19, 2024 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. The recall status is terminated (terminated November 12, 2025).
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2025
- Initiation Date
- December 19, 2024
- Termination Date
- November 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Reason for Recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Distribution Pattern
Nationwide in the USA
Code Information
Lot number: 243120003D, Use by Date: 03/11/2025