Drug product
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
D-0312-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36360 bags
- Official record key
drug-enforcement:D-0312-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21065/BQA 12-Nov-21 S21066/BQB 19-Nov-21 S21142/BTA 19-Nov-21 S21143/BTB 20-Nov-21 S21146/BTE 21-Nov-21 S21147/BTF 25-Nov-21 S21148/BTG 25-Nov-21 S21153/BTL 26-Nov-21 S21154/BTM 27-Nov-21 S21171/BUC 10-Dec-21 S21172/BUD 11-Dec-21 S21173/BUE 15-Dec-21 S21190/BUT 16-Dec-21 S21201/BVD 22-Dec-21 S21202/BVE 24-Dec-21 S21203/BVF 29-Dec-21 S21204/BVG 19-Jan-22 S21258/BXD 20-Jan-22 S21275/BXS 30-Jan-22 S21276/BXT 2-Feb-22 S21277/BXU 3-Feb-22 S21278/BXV 3-Feb-22 S21284/BYB 4-Feb-22 S21285/BYC 5-Feb-22 S21286/BYD 11-Feb-22 S21287/BYE 12-Feb-22 S21290/BYH 16-Feb-22 S21304/BYT 23-Feb-22 S21306/BYV 24-Feb-22 S21308/BYX 25-Feb-22 S21310/BYZ 26-Feb-22 S21379/CBM 14-Apr-22 S21382/CBP 14-Apr-22 S21385/CBS 15-Apr-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility