Drug product
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
D-0302-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24300 bags
- Official record key
drug-enforcement:D-0302-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots S21164/BTV, 3-Dec-21; S21191/BUU, 18-DEC-21; S21197/BUZ, 31-Dec-21; S21220/BVV, 13-Jan-22; S21271/BX0, 27-Jan-22; S21272/BXP, 28-Jan-22; S21299/BYP, 18-Fev-22; S21300/BYQ, 19-Feb-22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility