Recalls / Class II
Class IID-0147-2020
Product
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
- Affected lot / code info
- Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019
Why it was recalled
GMP Deviations: potential glass contamination
Recalling firm
- Firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 1855 bags
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-10-09
- FDA classified
- 2019-10-18
- Posted by FDA
- 2019-10-30
- Terminated
- 2020-12-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0147-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.