D-0169-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 23, 2020
- Initiation Date
- December 7, 2020
- Termination Date
- July 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,324,072 vials
Product Description
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
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.