Drug product
Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1234-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 syringes
- Official record key
drug-enforcement:D-1234-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED031915 Exp. 4/17/2019; ED041919 Exp. 4/18/2019; ED091914 Exp. 4/23/2019; ED111912 Exp. 4/25/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility