Drug product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
D-1062-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25529 syringes
- Official record key
drug-enforcement:D-1062-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 9910, 9928, BUD: 7/28/2017; 9962, 9993, BUD: 8/4/2017; 10333, 10481, 10538, BUD: 9/23/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility