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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug

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

Agency Publication Date: December 23, 2014
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Affected Products

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, M

Lot #: 3A350, Expiry: 01/16; Lot #: 3B351, Expiry: 02/16; Lot #: 3C352, Expiry: 03/16; Lot #: 3C353, Expiry: 03/16; Lot #: 3C354, Expiry: 03/16.

Lot Numbers:
3A350
3B351
3C352
3C353
3C354
Product: Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.

Lot #: 3A450, Expiry: 01/06.

Lot Numbers:
3A450
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, Pom

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.

Lot Numbers:
3B251
3B250
3B251
3C252
3C253
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

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.

Lot Numbers:
3A001
3A002
3B004
3B003
3C005
3C006
3D007
3D008

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69945
Status: Resolved
Manufacturer: K C Pharmaceuticals Inc
Manufactured In: United States
Units Affected: 4 products (427,512 Bottles; 71904 Bottles; 302,976 Bottles; 751,440 Bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.