Drug product
CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1227-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 syringes
- Official record key
drug-enforcement:D-1227-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: EB271907 Exp. 4/13/2019; ED041907 Exp. 5/19/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility