Drug 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.
D-0101-2021
Product summary
- Event
- Event 86685
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,100,646 Vials
- Official record key
drug-enforcement:D-0101-2021
Official wording
Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Code information: 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.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out of Specification