FDA Drugs recall ·
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL)… recall
- Recall number
- D-0174-2025
- Date
- (initiated December 19, 2024)
- Company / brand
- Hikma Injectables USA Inc
36 Stults Rd, Dayton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number: 243120003D, Use by Date: 03/11/2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0174-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.