Drug product
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
D-1233-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 bags
- Official record key
drug-enforcement:D-1233-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED041913 Exp. 4/13/2019; ED051913 Exp. 4/14/2019; ED081913 Exp. 4/17/2019; ED091913, ED091912 Exp. 4/18/2019; ED101914, ED101913 Exp. 4/19/2019; ED111911 Exp. 4/20/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility