Drug product
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1239-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 532 bags
- Official record key
drug-enforcement:D-1239-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED041919 Exp. 4/13/2019; ED051919 Exp. 4/14/2019; ED041919 Exp. 4/17/2019; ED091919 Exp. 4/18/2019; ED101919 Exp. 4/19/2019; ED111917 Exp. 4/20/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility