Drug product
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
D-1088-2020
Product summary
- Event
- Event 85212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 375 units
- Official record key
drug-enforcement:D-1088-2020
Official wording
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information: 193500012D, Exp 3/16/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility