Drug recall D-0101-2021
Product
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.
Lots and codes
a) Vial Lot #s: 078338 Exp. 7/2021; Lot 088391, Exp. 08/2021; 098340, Exp. 09/2021; 108325 Exp. 10/2021; 010018 Exp. 1/2023; b) Carton Lot #: 068322, Exp. 06/2021.
Recall details
- Recalling firm
- Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ
- Quantity
- 2,100,646 Vials
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 3, 2020
- Terminated
- November 17, 2022
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.