Drug product
fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72
D-0945-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 syringes
- Official record key
drug-enforcement:D-0945-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot #: 5/24/18 0502 149-21072S, BUD 8/22/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility