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.
US0.9% 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.
Recalling Firm: Huons Co., Ltd.
Motivo del Retiro / Peligro
TranslatedLack of Assurance of Sterility
Descripción del Producto e Identificación
Translated0.9% 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectr...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableHuons Co., Ltd.
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUSA Nationwide.
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🚨 SAFETY ALERT: Huons Co., Ltd. - 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. Check if your household is affected: https://therecallfile.com/es/recalls/0-9-sodium-chloride-injection-usp-10-ml-ampules-rx-only-single-dose-pr/FDA-D-0531-2026
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