Recalls / Class II
Class IID-1274-2022
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
- Affected lot / code info
- Lots: PE2001A, Exp. 7/1/2022; PE2003A, Exp. 7/12/2022; PE2013A, Exp. 8/29/2022; PE2014A, Exp. 10/5/2022
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
- 75,630 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-30
- FDA classified
- 2022-07-18
- Posted by FDA
- 2022-07-27
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1274-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.