Drug product
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
D-1085-2020
Product summary
- Event
- Event 85212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 units
- Official record key
drug-enforcement:D-1085-2020
Official wording
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information: 193610002D, Exp 3/29/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility