Why it was recalled
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Product description
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Lot numbers, UPCs & expiration codes
Lot #: 240310003D, Exp 6/4/2024
Where it was sold
CO, GA, PA, SD, WA
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-0508-2024
- Classification
- Class I
- Status
- Completed
- Recall initiated
- Apr 29, 2024
- FDA report date
- May 29, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Injectables USA Inc
Original FDA data
Every field from FDA enforcement report D-0508-2024, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 94522
- Address
- 36 Stults Rd
- Code information
- Lot #: 240310003D, Exp 6/4/2024
- Postal code
- 08810-1540
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0508-2024
- Classification
- Class I
- Recalling firm
- Hikma Injectables USA Inc
- Reason for recall
- Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
- Distribution pattern
- CO, GA, PA, SD, WA
- Recall initiation date
- Apr 29, 2024
- Initial firm notification
- Letter
- Center classification date
- May 23, 2024