Drug product
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
D-0169-2021
Product summary
- Event
- Event 86948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,324,072 vials
- Official record key
drug-enforcement:D-0169-2021
Official wording
Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Code information: Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification