Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile 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 69374-302-10.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: PE2025, Exp. 05/28/2023; PE2026, Exp. 06/02/2023; PE2027, Exp. 06/04/2023; PE2030, Exp. 06/29/2023; PE2031, Exp. 06/27/2023; PE2032, Exp. 07/09/2023; PE2032A, Exp. 07/09/2023; PE2033, Exp. 08/03/2023; PE2034, Exp. 08/31/2023; PE2035, Exp. 09/11/2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nephron Sterile Compounding Center LLC
- Reason for Recall:
- Lack of Assurance of Sterility
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile 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 69374-302-10.
Product Codes/Lot Numbers:
Lots: PE2025, Exp. 05/28/2023; PE2026, Exp. 06/02/2023; PE2027, Exp. 06/04/2023; PE2030, Exp. 06/29/2023; PE2031, Exp. 06/27/2023; PE2032, Exp. 07/09/2023; PE2032A, Exp. 07/09/2023; PE2033, Exp. 08/03/2023; PE2034, Exp. 08/31/2023; PE2035, Exp. 09/11/2023
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0359-2023
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