Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
USOasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
Recalling Firm: Oasis Medical, Inc.
Motif du rappel / Danger
TranslatedLack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Description du produit & Identification
TranslatedOasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
Additional Source Details
| Field | Value |
|---|---|
| City | Glendora |
| State | CA |
| Openfda › Nui › 1 | N0000185370 |
| Openfda › Nui › 2 | N0000175629 |
| Openfda › Nui › 3 | N0000184306 |
| Openfda › Nui › 4 | N0000185001 |
| Openfda › Nui › 5 | M0000728 |
| Openfda › Nui › 6 | M0009417 |
| Openfda › Unii | PDC6A3C0OX |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 310541 |
| Openfda › Rxcui › 2 | 1598052 |
| Openfda › Spl id | 58c4a89f-c811-462c-a212-fa35c2e46864 |
| Openfda › Brand name | OASIS TEARS PF |
| Openfda › Spl set id | 640f95f4-c2e8-48ad-ad40-f76bbaddb0dc |
| Openfda › Package ndc | 42126-6400-1 |
| Openfda › Product ndc | 42126-6400 |
| Openfda › Generic name | GLYCERIN |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs › 1 | Allergens [CS] |
| Openfda › Pharm class cs › 2 | Glycerol [CS] |
| Openfda › Pharm class pe › 1 | Increased Histamine Release [PE] |
| Openfda › Pharm class pe › 2 | Cell-mediated Immunity [PE] |
| Openfda › Pharm class pe › 3 | Increased IgG Production [PE] |
| Openfda › Substance name | GLYCERIN |
| Openfda › Pharm class epc | Non-Standardized Chemical Allergen [EPC] |
| Openfda › Manufacturer name | OASIS Medical, Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98897 |
| Address 1 | 510 S Vermont Ave # 528 |
| Code info | Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26. |
| Postal code | 91741-6205 |
| Report date | 20260520 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260427 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
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 Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medic...?
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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Aperçu
- Entreprise responsableOasis Medical, Inc.
- StatusOngoing
- Niveau de risqueClass II
- DistributionNationwide within the United States
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🚨 SAFETY ALERT: Oasis Medical, Inc. - Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1. Check if your household is affected: https://therecallfile.com/fr/recalls/oasis-tears-pf-preservative-free-lubricant-eye-drops-10ml-0-34-fl-oz-b/FDA-D-0525-2026
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