CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count bo...
Reason for Recall / Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Product Description & Identification
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,
Affected Products
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,
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 |
Overview
- Recalling FirmWizcure Pharmaa Private Limited
- StatusOngoing
- Risk LevelClass II
- DistributionDistributed Nationwide in the USA