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.
USUltra 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.
Recalling Firm: K.C. Pharmaceuticals, Inc
Motivo del Retiro / Peligro
TranslatedLack of Assurance of Sterility
Descripción del Producto e Identificación
TranslatedUltra 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEA...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableK.C. Pharmaceuticals, Inc
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionNationwide in the US
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Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: K.C. Pharmaceuticals, Inc - 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. Check if your household is affected: https://therecallfile.com/es/recalls/ultra-lubricating-eye-drops-polyethylene-400-0-4-propylene-glycol-0-3/FDA-D-0412-2026
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