Drug recall D-0169-2021
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
Reason for recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Lots and codes
Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 1,324,072 vials
- Distribution
- Distributed Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 7, 2020
- Terminated
- July 18, 2023
Related products
- Sodium Chloride – drug information
- NDC 0641-0497 Sodium Chloride · Sodium Chloride 9 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6144 Sodium Chloride · Sodium Chloride 9 mg/mL · Hikma Pharmaceuticals USA Inc.