Drug product
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
D-1081-2020
Product summary
- Event
- Event 85212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1075 units
- Official record key
drug-enforcement:D-1081-2020
Official wording
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information: 193500004D 3/16/2020 193510006D 3/17/2020 193530011D 3/19/2020 193570003D 3/23/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility