Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
USSystane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Recalling Firm: Alcon Research LLC
Grund für den Rückruf / Gefahr
TranslatedLack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Produktbeschreibung & Identifikation
TranslatedSystane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Additional Source Details
| Field | Value |
|---|---|
| City | Fort Worth |
| State | TX |
| Openfda › Upc | 0300650474016 |
| Openfda › Unii | RN3152OP35 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 310932 |
| Openfda › Spl id | 634b9bdb-004a-462e-ba48-1ab306157e02 |
| Openfda › Brand name | SYSTANE |
| Openfda › Spl set id | 5f74b161-ae41-d0e2-6ed9-8deca55d2c0f |
| Openfda › Package ndc › 1 | 0065-0474-01 |
| Openfda › Package ndc › 2 | 0065-0474-02 |
| Openfda › Product ndc | 0065-0474 |
| Openfda › Generic name | HYPROMELLOSE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | HYPROMELLOSE 2910 (4000 MPA.S) |
| Openfda › Manufacturer name | Alcon Laboratories, Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98815 |
| Address 1 | 6201 South Fwy |
| Code info | Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027. |
| Postal code | 76134-2099 |
| Report date | 20260506 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260421 |
| Initial firm notification | Letter |
| Center classification date | 20260424 |
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 Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., For...?
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.
Prüfen Sie weitere Produkte in Ihrem Haushalt
Kostenlose ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Übersicht
- Rückrufendes UnternehmenAlcon Research LLC
- StatusOngoing
- RisikostufeClass II
- DistributionNationwide within the United States
📢 Warnung teilen
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Alcon Research LLC - Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01 Check if your household is affected: https://therecallfile.com/de/recalls/systane-lubricant-eye-gel-night-gel-sterile-10g-0-35-oz-processed-in-f/FDA-D-0491-2026
Alarm-Liste abonnieren
Erhalten Sie sofortige E-Mail-Benachrichtigungen bei kritischen Produktrückrufen.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Ähnliche Rückrufe
FDA DrugsLevothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
FDA DrugsRamipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
FDA DrugsLevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Subpotent Drug