Drug product
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.
D-0220-2018
Product summary
- Event
- Event 78683
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5002 syringes
- Official record key
drug-enforcement:D-0220-2018
Official wording
Reason: Subpotent Drug
Code information: Lot #: 172950036M, Exp. 1/21/2018; 172940003M, Exp. 1/20/2018; 172880044M, Exp. 1/14/2018; 172840176M, Exp. 1/11/2018; 172920115M, Exp. 1/18/2018; 172840015D, Exp. 1/10/2018; 172930139M, Exp. 1/19/2018.
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Subpotent