Drug product
EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.
D-0932-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 bags
- Official record key
drug-enforcement:D-0932-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot # 4/30/18 0512 2-82325P, BUD 6/14/2018; 5/22/18 1238 82325P, BUD 7/6/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility