Drug product
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
D-1091-2020
Product summary
- Event
- Event 85212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 900 units
- Official record key
drug-enforcement:D-1091-2020
Official wording
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information: 193520006D 3/18/2020 193530009D 3/19/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility