FDA Drug recall D-0169-2021
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by
- FDA Drug
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by by Hikma Pharmaceuticals Usa, citing failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0169-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-07 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
Product
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
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Identifiers
| ndc | 0641-0497-17 |
|---|---|
| ndc | 0641-0497-25 |
| ndc | 0641-6144-01 |
| ndc | 0641-6144-25 |
| code_info | Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.