FDA DrugsClass II
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drop...
Published: March 4, 2026Recall ID: D-0346-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Product Description & Identification
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Additional Source Details
| Field | Value |
|---|---|
| City | Bhiwadi |
| State | N/A |
| 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 | 5,760 cartons |
| 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