Drug recalls

Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmac…

K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility

Class IIOngoingD-0005-2027
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
E-Mail
Distribution pattern
US Nationwide
Recall number
D-0005-2027
Product quantity
1,435,830 cartons
Reason for recall
Lack of Assurance of Sterility
Recall initiation date
20260911
Center classification date
20261005
Report date
20261014
Product description

Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 89636 9; b) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 73589 8; c) TYSON, MIKE RED EYE DROPS, Distributed by: JBRANDS Distribution, Miami, FL 33009, UPC: 7 84847 57549 4; d) up & up, Distributed by: Target Corporation, Minneapolis, MN 55403, NDC 11673-100-01; e) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 21123 0; f) Walgreens, DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20075 0.

Code info

Lot: a) CM25E02, Exp.: 5/31/2027; CM25M01, Exp.: 10/31/2027; b) CM25E02, Exp.: 5/31/2027; c) CM25C01, Exp.: 3/31/2027; CM25C02, Exp.: 3/31/2027; CM25C03, Exp.: 3/31/2027; CM25E02, Exp.: 5/31/2027; CM25F01, Exp.: 6/30/2027; CM25A02, Exp.: 1/1/2027; CM25B01, Exp.: 2/28/2027; d) CM25B01, Exp.: 2/28/2027; CM25E01, Exp.: 5/31/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; e) CM25B01, Exp.: 2/28/2027; CM25F01, Exp.: 6/30/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; f) CM25B01, Exp.: 2/28/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027.

Harmonized identifiers (openFDA)
Application number
M018
Brand name
TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE
Generic name
GLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Manufacturer name
Target Corporation
Product NDC
11673-100
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Substance name
GLYCERIN, NAPHAZOLINE HYDROCHLORIDE
RxCUI
1235200
SPL ID
0cfa0b71-d377-fa73-e063-6294a90a390e
SPL set ID
1b26cd3b-4a05-4623-b320-01f22b3106ff
Package NDC
11673-100-01
Is original packager
true
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, MZ1131787D
Upc
614299896369, 072036735898, 784847575494, 036800211230, 311917200750
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.