Drug product
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
D-0148-2020
Product summary
- Event
- Event 84000
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1370 bags
- Official record key
drug-enforcement:D-0148-2020
Official wording
Reason: GMP Deviations: potential glass contamination
Code information: Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
GMP Deviations