FDA Drug recall D-0101-2021
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.…
- FDA Drug
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of 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 Hikma Pharmaceuticals Usa, citing failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0101-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-03 |
| Published | 2020-11-25 |
| 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, 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
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Identifiers
| ndc | 0641-0497-17 |
|---|---|
| ndc | 0641-0497-25 |
| ndc | 0641-6144-01 |
| ndc | 0641-6144-25 |
| code_info | a) Vial Lot #s: 078338 Exp. 7/2021; Lot 088391, Exp. 08/2021; 098340, Exp. 09/2021; 108325 Exp. 10/2021; 010018 Exp. 1/…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. |
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-0101-2021%22
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