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
Reported: December 23, 2020 Initiated: December 7, 2020 #D-0169-2021
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.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 1,324,072 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 1,324,072 vials.
Why was this product recalled? ▼
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0169-2021.
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