FDA DrugsClass II
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, M...
Published: May 6, 2026Recall ID: D-0499-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.
Additional Source Details
| Field | Value |
|---|---|
| City | New York |
| State | NY |
| 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 | 998232 |
| Openfda › Spl id | 49a44c61-bccb-ab89-e063-6394a90aa2b1 |
| Openfda › Brand name | OPTASE |
| Openfda › Spl set id | 9e96976b-2990-79e0-e053-2995a90a0f29 |
| Openfda › Package ndc | 72972-002-01 |
| Openfda › Product ndc | 72972-002 |
| 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 | Scope Health Inc |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98802 |
| Address 1 | 79 Madison Avenue |
| Address 2 | 27 E 28th St |
| Code info | Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27. |
| Postal code | 10016-7921 |
| Report date | 20260506 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260420 |
| Initial firm notification | Letter |
| Center classification date | 20260428 |
Overview
- Recalling FirmSCOPE HEALTH
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States