Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.…
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-0006-2027
- Product quantity
- 1,327,248 cartons
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation date
- 20260911
- Center classification date
- 20261005
- Report date
- 20261014
- Product description
Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.
- Code info
Lot: a) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027.
- Harmonized identifiers (openFDA)
- Application number
- M018
- Brand name
- LEADER DRY EYE RELIEF EYE DROPS, ARTIFICIAL TEARS, FOSTER AND THRIVE DRY EYE RELIEF
- Generic name
- GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, GLYCERIN, POLYETHYLENE GLYCOL 400
- Manufacturer name
- CARDINAL HEALTH 110, LLC. DBA LEADER, Geri-Care Pharmaceuticals, Corp, Strategic Sourcing Services LLC
- Product NDC
- 70000-0502, 57896-181, 70677-1157
- Product type
- HUMAN OTC DRUG
- Route
- OPHTHALMIC
- Substance name
- GLYCERIN, HYPROMELLOSE, UNSPECIFIED, POLYETHYLENE GLYCOL 400, HYPROMELLOSES
- RxCUI
- 259581, 2360899
- SPL ID
- 5944f7bf-c84b-497f-e063-6394a90aed1f, 472b069b-4e80-8cb8-e063-6294a90a302b, 4749275b-6982-4eaf-e063-6394a90aaee9
- SPL set ID
- 2ded4bda-b3c3-4521-8701-5c8446fd148b, 7cc437e3-bad9-59be-e053-2991aa0a1da3, 0018ade9-5856-db6c-e063-6394a90a2ccf
- Package NDC
- 70000-0502-1, 70000-0502-2, 57896-181-05, 70677-1157-1
- Is original packager
- true
- Upc
- 0096295137064, 0096295137071, 0357896184056, 0010939958266, 867166000004, 093351011566, 614299056206, 041220437412, 072036713032, 036800361003
- Nui
- N0000185370, N0000175629, N0000184306, N0000185001, M0000728, M0009417
- Pharm class epc
- Non-Standardized Chemical Allergen [EPC]
- Pharm class pe
- Increased Histamine Release [PE], Cell-mediated Immunity [PE], Increased IgG Production [PE]
- Pharm class cs
- Allergens [CS], Glycerol [CS]
- UNII
- PDC6A3C0OX, 3NXW29V3WO, B697894SGQ