Recalls / Class II
Class IID-0362-2023
Product
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
- Affected lot / code info
- Lots: PS2008A, Exp. 03/07/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 10,980 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-02-22
- FDA classified
- 2023-02-27
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0362-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.