Drug product
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
D-0149-2020
Product summary
- Event
- Event 84000
- Status
- Terminated
- Classification
- Class II
- Quantity
- 615 bags
- Official record key
drug-enforcement:D-0149-2020
Official wording
Reason: GMP Deviations: potential glass contamination
Code information: Lot: FR9002A Exp. 12/12/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
GMP Deviations