CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
USCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Recalling Firm: Wizcure Pharmaa Private Limited
Grund für den Rückruf / Gefahr
TranslatedLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Produktbeschreibung & Identifikation
TranslatedCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Betroffene Produkte
TranslatedCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Additional Source Details
| Field | Value |
|---|---|
| City | Bhiwadi |
| State | N/A |
| Openfda › Unii | 93X55PE38X |
| Openfda › Route | OPHTHALMIC |
| Openfda › Spl id | 386aaf96-81c0-bd6f-e063-6394a90ad761 |
| Openfda › Brand name | C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS |
| Openfda › Spl set id | 292abb69-84ad-4f61-e063-6394a90a1447 |
| Openfda › Package ndc › 1 | 83851-100-10 |
| Openfda › Package ndc › 2 | 83851-100-30 |
| Openfda › Package ndc › 3 | 83851-100-05 |
| Openfda › Product ndc | 83851-100 |
| Openfda › Generic name | FLUORESCEIN SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | FLUORESCEIN SODIUM |
| Openfda › Manufacturer name | Vistamerica USA |
| Openfda › Is original packager | true |
| Event id | 98253 |
| Address 1 | H - 881 |
| Address 2 | N/A |
| Code info | All lots |
| Postal code | N/A |
| Report date | 20260304 |
| Product type | Drugs |
| Product quantity | 10,080 boxes |
| Reason for recall | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251231 |
| Initial firm notification | Letter |
| Center classification date | 20260225 |
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 CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box...?
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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Übersicht
- Rückrufendes UnternehmenWizcure Pharmaa Private Limited
- StatusOngoing
- RisikostufeClass II
- DistributionDistributed Nationwide in the USA
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Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Wizcure Pharmaa Private Limited - CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, Check if your household is affected: https://therecallfile.com/de/recalls/chnao-fluorescein-sodium-ophthalmic-strips-usp-1mg-packaged-as-a-100-c/FDA-D-0350-2026
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