Drug product
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
D-0300-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15660 bags
- Official record key
drug-enforcement:D-0300-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots S21131/BSP, 10-Nov-21 S21132/BSQ, 11-Nov-21 S21139/BSX, 18-Nov-21 S21150/BTI, 24-Nov-21 S21158/BTP, 1-Dec-21 S21160/BTR, 2-Dec-21 & S21170/BUB, 9-Dec-21.
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility