FDA DrugsClass II
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preser...
Published: April 22, 2026Recall ID: D-0531-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Additional Source Details
| Field | Value |
|---|---|
| City | Jecheon |
| State | N/A |
| Openfda › Unii | 451W47IQ8X |
| Openfda › Route › 1 | INTRAMUSCULAR |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Route › 3 | SUBCUTANEOUS |
| Openfda › Rxcui › 1 | 1807637 |
| Openfda › Rxcui › 2 | 1807646 |
| Openfda › Spl id | 447bf261-1a3a-2da1-e063-6394a90a7537 |
| Openfda › Brand name | SODIUM CHLORIDE |
| Openfda › Spl set id | 7e316d21-d6ad-4976-bd90-268fd7e51361 |
| Openfda › Package ndc › 1 | 65282-1510-1 |
| Openfda › Package ndc › 2 | 65282-1505-1 |
| Openfda › Product ndc › 1 | 65282-1505 |
| Openfda › Product ndc › 2 | 65282-1510 |
| Openfda › Generic name | SODIUM CHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | SODIUM CHLORIDE |
| Openfda › Manufacturer name | Spectra Medical Deviecs, LLC |
| Openfda › Application number | ANDA206171 |
| Openfda › Is original packager | true |
| Event id | 98724 |
| Address 1 | 100 Bio-Valley-Ro |
| Address 2 | N/A |
| Code info | All lots within expiry |
| Postal code | N/A |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | 7,120,750 ampules |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | N/A |
| Center classification date | 20260515 |
Overview
- Recalling FirmHuons Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide.