FDA Drug recall D-0321-2015

Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter

• FDA Drug
• Class III
• terminated
• Published 2014-12-31

On 2014-12-31 the FDA classified a Class III recall of Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter by K C Pharmaceuticals, citing CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Read the official FDA Drug notice

Product

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, Pomona, CA 91768, UPC: 1 80410 00018 7, NDC: 48879-010-07; e) H-E-B, Made for: H-E-B, San Antonio, TX 78204, UPC: 0 41220 86936 7; f) healthy accents, Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93382 7; g) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29777 5; h) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38599 4; i) life, Imported for/Importe pour: SHOPPERS DRUG MART PHARMAPRIX., Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 19617 4; j) LiveBetter, Distributed By Onpoint. Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62041 0; k) meijer, Dist. by Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82918 8; l) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01176 2; m) QUALITY CHOICE, Distributed by Quality Choice, Novi, MI 48376, UPC: 6 35515 99505 5; n) REDNESS RELIEF ASTRINGENT, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC: 0 50428 79686 3; o)Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; p) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; q) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00363 6; r) Smart sense, Distributed by: Kmart Corporation, Hoffman Estates, IL 60179, UPC: 7 20007 96092 2; s) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03640 6; t)WESTERN FAMILY, Distributed by Western Family Foods, Inc., P.O. Box 4057 Portland, OR 97208, UPC: 0 15400 04552 0.

Reason

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0321-2015%22

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