Sodium Chloride Injection — Class II drug recall D-0101-2021
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2020-11-25, distributed nationwide. Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9
| Recall number | D-0101-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2020-11-03 |
| Classified | 2020-11-20 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2022-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,100,646 vials |
| Reason classes | specification failure |
| NDC | 00641-0497, 00641-0497-17, 00641-0497-25, 00641-6144, 00641-6144-01, 00641-6144-25 |
| Lot numbers | 010018, 068322, 078338, 088391, 098340, 108325 |
| Expiration dates | 2021-06, 2021-07, 2021-08, 2021-09, 2021-10, 2023-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0101-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.