Drug product
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
D-0355-2023
Product summary
- Event
- Event 91749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,743 bottles
- Official record key
drug-enforcement:D-0355-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: DS2053, Exp. 2/27/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility