FDA Drug Class III — Least Serious

Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47010 6; c) EQUALINE, Distributed by Supervalu Inc., Eden Prairie, MN, UPC: 0 41163 25114 4; d) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pom

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 A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasa
Brand
K C Pharmaceuticals Inc
UPC
Lot #: 3B251, Expiry: 02/16; Lot #: 3B250, Expiry: 02/16; Lot #: 3B251, Expiry: 02/16; Lot #: 3C252, Expiry: 03/16; Lot #: 3C253, Expiry: 03/16.

Units Affected

302,976 Bottles