FDA Drug recall D-0323-2015

Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles…

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

On 2014-12-31 the FDA classified a Class III recall of Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles… 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 Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Advanced Relief, Distributed by Safeway Inc., P.O.Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70064 7; b) Best Choice, Distributed By: Valu Mercahndisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47009 0; c) EQUALINE, Distributed By Supervalu Inc., Eden Prairie, MN 55344, UPC: 0 41163 25392 6; d) equate, Manufactured for/Fabrique pour: Wal-Mart Canada Corp, 1940 Argentia Rd, Mississauga Ontario L5N 1P9, Imported by/ Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 1 83164 00022 9; e) exchange select, Manufactured For: Your Military Exchanges By: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 6 14299 39625 8; f) GOOD NEIGHBOR PHARMACY, Distributed By AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087, UPC: 0 87701 10663 7, NDC: 24385-077-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00019 4, NDC: 48879-007-07; h) H-E-B, Made for H-E-B, San Antonio, TX 78204, UPC: 0 41220 89137 5; i) Health Mart, Distributed by McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 52569 13474 0, NDC: 62011-0104-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, NDC: 7 25439 93383 4; k) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29778 2; l) Kroger, Distributed by The Kroger Co., Ohio 45202, UPC: 0 11110 38598 7; m) life, Imported for/ Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 15640 6; n) LiveBetter, Distributed by Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62043 4; o) Medic's Choice, KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 0 95072 01251 8, NDC: 055654-025; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82917 1; q) Our Family, Distributed by NASH FINCH COMPANY, NFC Brands, 7600 France Ave S, MPLS 55435, UPC: 0 70253 96683 5; r) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 06776 9; s) Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L5N 2B8, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10462 8; t) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L5N 2B8, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10462 8; u) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00364 3; v) sunmark, Distributed By McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 10939 16833 7, NDC: 49348-697-29; w) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03641 3; x) WESTERN FAMILY, Distributed by Western Family Foods, Imc., P.O.Box 4057, Portland OR 97208, UPC: 0 15400 03281 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-0323-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.