Drug 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
D-0147-2020
Product summary
- Event
- Event 84000
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1855 bags
- Official record key
drug-enforcement:D-0147-2020
Official wording
Reason: GMP Deviations: potential glass contamination
Code information: Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
GMP Deviations