Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DI…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- Status
- Ongoing
- City
- Pomona
- State
- CA
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99880
- Recalling firm
- K.C. Pharmaceuticals, Inc.
- Address 1
- 3420 Pomona Blvd
- Address 2
- N/A
- Postal code
- 91768-3236
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Distribution pattern
- US Nationwide
- Recall number
- D-0002-2027
- Product quantity
- 505,896 cartons
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation date
- 20260911
- Center classification date
- 20261005
- Report date
- 20261014
- Product description
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.
- Code info
Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026.
- Harmonized identifiers (openFDA)
- Application number
- M018
- Brand name
- LEADER ARTIFICIAL TEARS 15 ML, GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS, GOOD SENSE ARTIFICIAL TEARS, ARTIFICIAL TEARS, QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS
- Generic name
- POLYVINYL ALCOHOL, POVIDONE
- Manufacturer name
- Cardinal Health, AmerisourceBergen, Geiss, Destin & Dunn, Inc., KC Pharmaceuticals, Inc., Chain Drug Marketing Association, Inc.
- Product NDC
- 70000-0011, 24385-006, 50804-110, 55651-008, 83324-189
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Substance name
- POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, POVIDONE, UNSPECIFIED, POLYVINYL ALCOHOL
- RxCUI
- 598050
- SPL ID
- 5b120e34-0a0e-e1ae-e063-6294a90a15bc, 5739a45b-5bf7-5db8-e063-6394a90a7ffc, 47450941-e9fd-623c-e063-6294a90a940b, 4748d0f4-e97c-a0c1-e063-6394a90ac311, 47494778-349f-6448-e063-6294a90a3c34
- SPL set ID
- 8cccc589-3a8e-baad-e053-2a95a90ab8c7, ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f, 9b243301-2e4b-5706-e053-2995a90a9b90, eb6eb6c4-1609-407b-84e4-c7509811f3c0, 1f669655-4bc7-0175-e063-6294a90a305a
- Package NDC
- 70000-0011-1, 24385-006-05, 50804-110-01, 55651-008-01, 83324-189-14
- Is original packager
- true
- Upc
- 0096295137644, 0087701104060, 0180410000163, 0095072015519, 0635515992238, 070038470083, 041415009769, 036800093317, 311917065038, 011110386007
- UNII
- 532B59J990, FZ989GH94E