Eye Drops (K C Pharmaceuticals) – Non-Compliant Storage (2014)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3; c) Equaline, DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344, UPC: 0 41163 25110 6; d) exact, Prepared For/Prepare Pour: Loblaws Inc., Montreal H4N 3L4, Tonronto M4T 2S8, Calgary T2E 7S9, CANADA, Impor
Brand
K C Pharmaceuticals Inc
Lot Codes / Batch Numbers
Lot #: 3A001, Expiry: 01/16, Lot #: 3A002, Expiry: 01/16, Lot #: 3B004, Expiry: 02/16, Lot #: 3B003, Expiry: 02/16, Lot #: 3C005, Expiry: 03/16, Lot #: 3C006, Expiry: 03/16, Lot #: 3D007, Expiry: 04/16, Lot #: 3D008, Expiry: 04/16.
Products Sold
Lot #: 3A001, Expiry: 01/16; Lot #: 3A002, Expiry: 01/16; Lot #: 3B004, Expiry: 02/16; Lot #: 3B003, Expiry: 02/16; Lot #: 3C005, Expiry: 03/16; Lot #: 3C006, Expiry: 03/16; Lot #: 3D007, Expiry: 04/16; Lot #: 3D008, Expiry: 04/16.
K C Pharmaceuticals Inc is recalling Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Bes due to CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026