Drug product
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
D-1092-2020
Product summary
- Event
- Event 85212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
drug-enforcement:D-1092-2020
Official wording
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information: 193530007D, Exp 3/19/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility