FDA Drug Class III — Least Serious

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

Hazard

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Products

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 4
Brand
K C Pharmaceuticals Inc
UPC
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.

Units Affected

751,440 Bottles