Drug product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
D-1064-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49666 syringes
- Official record key
drug-enforcement:D-1064-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 9904, 9914, 9939, BUD: 7/28/2017; 9952, 9969, 10004, BUD: 8/4/2017; 10043, 10088, 10115, BUD: 8/17/2017; 10269, BUD: 9/8/2017;10431, BUD: 9/23/2017; 10554, BUD: 10/27/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility