FDA DrugsClass II
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran...
Published: May 6, 2026Recall ID: D-0491-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Product Description & Identification
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
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 |
Overview
- Recalling FirmAlcon Research LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States