Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Reported: November 25, 2020 Initiated: November 3, 2020 #D-0101-2021
Product Description
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 2,100,646 Vials
- Distribution
- Nationwide in the U.S.
- 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, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 2,100,646 Vials.
Why was this product recalled? ▼
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2020. Severity: Moderate. Recall number: D-0101-2021.
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