Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0...
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14
Additional Source Details
| Field | Value |
|---|---|
| City | Pomona |
| State | CA |
| Openfda › Upc › 1 | 0096295137644 |
| Openfda › Upc › 2 | 0180410000163 |
| Openfda › Upc › 3 | 0087701104060 |
| Openfda › Upc › 4 | 0635515992238 |
| Openfda › Upc › 5 | 036800093317 |
| Openfda › Upc › 6 | 070038470083 |
| Openfda › Upc › 7 | 011110386007 |
| Openfda › Upc › 8 | 041415009769 |
| Openfda › Unii › 1 | 532B59J990 |
| Openfda › Unii › 2 | FZ989GH94E |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 598050 |
| Openfda › Spl id › 1 | 0d376274-1a79-5fbc-e063-6394a90a2cf2 |
| Openfda › Spl id › 2 | 47450941-e9fd-623c-e063-6294a90a940b |
| Openfda › Spl id › 3 | 0cfa48cc-26b5-c528-e063-6394a90a3aa9 |
| Openfda › Spl id › 4 | 47494778-349f-6448-e063-6294a90a3c34 |
| Openfda › Brand name › 1 | LEADER ARTIFICIAL TEARS 15 ML |
| Openfda › Brand name › 2 | GOOD SENSE ARTIFICIAL TEARS |
| Openfda › Brand name › 3 | GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS |
| Openfda › Brand name › 4 | QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS |
| Openfda › Spl set id › 1 | 8cccc589-3a8e-baad-e053-2a95a90ab8c7 |
| Openfda › Spl set id › 2 | 9b243301-2e4b-5706-e053-2995a90a9b90 |
| Openfda › Spl set id › 3 | ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f |
| Openfda › Spl set id › 4 | 1f669655-4bc7-0175-e063-6294a90a305a |
| Openfda › Package ndc › 1 | 70000-0011-1 |
| Openfda › Package ndc › 2 | 50804-110-01 |
| Openfda › Package ndc › 3 | 24385-006-05 |
| Openfda › Package ndc › 4 | 83324-189-14 |
| Openfda › Product ndc › 1 | 70000-0011 |
| Openfda › Product ndc › 2 | 50804-110 |
| Openfda › Product ndc › 3 | 24385-006 |
| Openfda › Product ndc › 4 | 83324-189 |
| Openfda › Generic name | POLYVINYL ALCOHOL, POVIDONE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | POLYVINYL ALCOHOL, UNSPECIFIED |
| Openfda › Substance name › 2 | POVIDONE |
| Openfda › Substance name › 3 | POLYVINYL ALCOHOL |
| Openfda › Manufacturer name › 1 | Cardinal Health |
| Openfda › Manufacturer name › 2 | Geiss, Destin & Dunn, Inc. |
| Openfda › Manufacturer name › 3 | AmerisourceBergen |
| Openfda › Manufacturer name › 4 | Chain Drug Marketing Association, Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98533 |
| Address 1 | 3420 Pomona Blvd |
| Code info | Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26. |
| Postal code | 91768-3236 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 589,848 bottles |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | |
| Center classification date | 20260331 |
Overview
- Recalling FirmK.C. Pharmaceuticals, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the US