Why it was recalled
Lack of Assurance of Sterility
Product description
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
Lot numbers, UPCs & expiration codes
Lots: PE2028, Exp. 06/15/2023
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-0360-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 31,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-0360-2023, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 91749
- Address
- 4500 12th Street Ext
- Code information
- Lots: PE2028, Exp. 06/15/2023
- Postal code
- 29172-3025
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0360-2023
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 31,500 vials
- Termination date
- Sep 24, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2023