Drug product
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
D-0889-2018
Product summary
- Event
- Event 80354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 syringes
- Official record key
drug-enforcement:D-0889-2018
Official wording
Reason: Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Code information: Lot #: 6/12/18 0432 149-21072S, BUD 9/10/18
Distribution pattern: Distributed to one medical center in Fort Worth, TX.
Derived failure modes
-
Potency or specification failure
Subpotent