Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Ster...
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9.
Additional Source Details
| Field | Value |
|---|---|
| City | Pomona |
| State | CA |
| Openfda › Upc › 1 | 0096295137101 |
| Openfda › Upc › 2 | 0010939958297 |
| Openfda › Upc › 3 | 0846036008210 |
| Openfda › Upc › 4 | 0713733428897 |
| Openfda › Upc › 5 | 0708820179288 |
| Openfda › Upc › 6 | 0635515999305 |
| Openfda › Upc › 7 | 072036735881 |
| Openfda › Upc › 8 | 311917201672 |
| Openfda › Upc › 9 | 041415098763 |
| Openfda › Upc › 10 | 050428396902 |
| Openfda › Upc › 11 | 050428447383 |
| Openfda › Upc › 12 | 857005004119 |
| Openfda › Unii › 1 | B697894SGQ |
| Openfda › Unii › 2 | 6DC9Q167V3 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 477589 |
| Openfda › Spl id › 1 | 4ccccdc5-a8f7-6d26-e063-6394a90a8795 |
| Openfda › Spl id › 2 | 47491cc4-1a66-464e-e063-6394a90a2770 |
| Openfda › Spl id › 3 | 474511c4-1fbd-70b8-e063-6294a90af8e8 |
| Openfda › Spl id › 4 | 0d22c2c2-a708-2509-e063-6294a90ae206 |
| Openfda › Spl id › 5 | 4749597d-57d5-92b6-e063-6294a90ab574 |
| Openfda › Brand name › 1 | LEADER ULTRA LUBRICATING EYE DROPS |
| Openfda › Brand name › 2 | FOSTER AND THRIVE LUBRICATING TEARS LUBRICANT EYE DROPS |
| Openfda › Brand name › 3 | GOODSENSE ULTRA LUBRICANT EYE DROPS |
| Openfda › Brand name › 4 | MEIJER ULTRA LUBRICANT EYE DROPS HIGH PERFORMANCE |
| Openfda › Brand name › 5 | QUALITY CHOICE LUBRICANT EYE DROPS HIGH PERFORMANCE |
| Openfda › Spl set id › 1 | d7f011a2-05ba-47c3-9519-d31602e105c7 |
| Openfda › Spl set id › 2 | 0042337b-c22a-157a-e063-6394a90a202e |
| Openfda › Spl set id › 3 | 9b45ebb5-c43b-c9fb-e053-2a95a90a3411 |
| Openfda › Spl set id › 4 | a0846e3e-687c-fd55-e053-2995a90a673e |
| Openfda › Spl set id › 5 | 0cd1b36a-a07a-a1db-e063-6294a90a5994 |
| Openfda › Package ndc › 1 | 70000-0457-1 |
| Openfda › Package ndc › 2 | 70000-0457-2 |
| Openfda › Package ndc › 3 | 70677-1160-1 |
| Openfda › Package ndc › 4 | 50804-160-01 |
| Openfda › Package ndc › 5 | 41250-937-01 |
| Openfda › Package ndc › 6 | 41250-937-02 |
| Openfda › Package ndc › 7 | 83324-029-15 |
| Openfda › Product ndc › 1 | 70000-0457 |
| Openfda › Product ndc › 2 | 70677-1160 |
| Openfda › Product ndc › 3 | 50804-160 |
| Openfda › Product ndc › 4 | 41250-937 |
| Openfda › Product ndc › 5 | 83324-029 |
| Openfda › Generic name | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | POLYETHYLENE GLYCOL 400 |
| Openfda › Substance name › 2 | PROPYLENE GLYCOL |
| Openfda › Manufacturer name › 1 | Cardinal Health |
| Openfda › Manufacturer name › 2 | Strategic Sourcing Services LLC |
| Openfda › Manufacturer name › 3 | Geiss, Destin & Dunn, Inc. |
| Openfda › Manufacturer name › 4 | Meijer Distribution, Inc. |
| Openfda › Manufacturer name › 5 | Chain Drug Marketing Assoc., Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98533 |
| Address 1 | 3420 Pomona Blvd |
| Code info | Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU24E01, Exp.: 5/31/26; i) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; j) SU24E03, Exp.: 5/31/26; k) SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; L) SU24K01, Exp.: 9/30/26. |
| Postal code | 91768-3236 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 245,184 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