Recalls / Class II
Class IID-0966-2022
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
- Affected lot / code info
- Lots: PE1107A, Exp. 5/22/2022; PE1123A, Exp. 6/21/2022; PE2007A, Exp. 8/4/2022; PE2012A, Exp. 8/28/2022
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
- 76860 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-05-18
- FDA classified
- 2022-05-27
- Posted by FDA
- 2022-06-08
- Terminated
- 2024-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0966-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.