Drug product
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
D-0315-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8946 bags
- Official record key
drug-enforcement:D-0315-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S21200/BVC 15-Nov-21 S21296/BYM 19-Dec-21 S21320/BZG 4-Jan-22 S21164/BTV 3-Dec-21 S21191/BUU 18-Dec-21 S21197/BUZ 31-Dec-21 S21220/BVV 13-Jan-22 S21271/BXO 27-Jan-22 S21272/BXP 28-Jan-22 S21299/BYP 18-Feb-22 S21300/BYQ 19-Feb-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility