Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles…
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-0004-2027
- Product quantity
- 208,896 cartons
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation date
- 20260911
- Center classification date
- 20261005
- Report date
- 20261014
- Product description
Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3.
- Code info
Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027.
- Harmonized identifiers (openFDA)
- Application number
- M018
- Brand name
- LEADER ADVANCED RELIEF EYE DROPS, GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER, MEDICS CHOICE EYE DROPS ADVANCED, FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS, QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS
- Generic name
- DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL
- Manufacturer name
- Cardinal Health, Geiss, Derstin & Dunn, Inc., KC Pharmaceuticals, Inc., Strategic Sourcing Services LLC, Chain Drug Marketing Association, Inc.
- Product NDC
- 70000-0456, 50804-130, 55651-025, 70677-1158, 83324-191
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Substance name
- DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE
- RxCUI
- 996202, 996209
- SPL ID
- 4ccce313-8eec-8a62-e063-6394a90aa128, 47450d1c-db32-92cd-e063-6394a90a0703, 4748d5b2-f2f1-e88b-e063-6394a90af39a, 474922b2-773c-4cff-e063-6394a90a6b3a, 4749597d-57d8-92b6-e063-6294a90ab574
- SPL set ID
- 5c5d6c13-9b51-48f0-8627-b60b0f707fd3, 9b34de99-13df-201a-e053-2a95a90ae559, ab906fd8-265c-4359-a920-d626366e245c, 0019cd99-b245-2ffc-e063-6294a90a9f27, 1fb81759-5931-59c8-e063-6294a90a2277
- Package NDC
- 70000-0456-1, 50804-130-01, 55651-025-01, 70677-1158-1, 83324-191-14
- Is original packager
- true
- Upc
- 0096295136470, 0180410000194, 0095072012518, 0010939958273, 0635515903760, 041163253926, 041220437450, 184125000180, 041415067769, 036800036413
- Nui
- N0000184175, N0000009361, N0000010288
- Pharm class epc
- Plasma Volume Expander [EPC]
- Pharm class pe
- Increased Intravascular Volume [PE]
- Pharm class moa
- Osmotic Activity [MoA]
- UNII
- 7SA290YK68, B697894SGQ, FZ989GH94E, 0YZT43HS7D