Why it was recalled
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
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
Lot numbers, UPCs & expiration codes
Lot number: 243120003D, Use by Date: 03/11/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0174-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 19, 2024
- FDA report date
- Jan 8, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Injectables USA Inc
Original FDA data
Every field from FDA enforcement report D-0174-2025, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 95993
- Address
- 36 Stults Rd
- Code information
- Lot number: 243120003D, Use by Date: 03/11/2025
- Postal code
- 08810-1540
- Report date
- Jan 8, 2025
- Product type
- Drugs
- Recall number
- D-0174-2025
- Classification
- Class II
- Recalling firm
- Hikma Injectables USA Inc
- Termination date
- Nov 12, 2025
- Reason for recall
- Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 19, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2025