Hearth Record

Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ

Medicine recall D-0320-2015. Published in FDA’s Enforcement Report on Dec 31, 2014.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Dec 31, 2014. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class III, the least serious of FDA’s three classes.

“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”

openFDA, in plain words, its enforcement report fields.

“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

FDA’s rule, 21 CFR 7.3(m)(3), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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

Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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, Imported by/Importe par: Arrow OTC, Mississauga, ON L5N 2B8, UPC: 0 60383 73613 2; e) FAMILY wellness, Distributed by: Family Dollar Services, Inc., 10401 Monroe Rd., Matthews, NC 28105, UPC: 0 32251 00459 9; f) Good Neighbor Pharmacy, Distributed By: AmerisourceBergen 1300 Moris Drive, Chesterbrook, PA 19087, UPC: 0 87701 14975 7, NDC: 24385-075-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00015 6, NDC: 48879-009-07; h) H-E-B, Made with Pride and Care for H-E-B, San Antonio, TX 78204, UPC: 0 41220 94731 7; i) Health Mart PHARMACY, Distributed by McKesson One Post STreet, San Francisco, CA 94104, UPC: 0 52569 13472 6, NDC: 62011-0102-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93380 3; k) HyVee, Distributed by HY-VEE, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29604 4; l) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38597 0; m) life BRAND, Imported for SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 057800-19616-7; n) life BRAND, Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 0 57800 19616 7; o) LiveBetter, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62042 7; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82916 4; q) Our Family, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN, 55435, UPC: 0 70253 96684 2; r) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01076 5; s) Redness Relief, Distributed by: Safeway Inc., P.O. BOX 99, PLEASANTON, CA 94566-0009, UPC: 3 21130 70060 9; t) Rexall, Manufactured For: Rexall Brads Corp., Mississauga, Ontario, L4Z 1R9., Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10160 4; u) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1%9, Importe par: Arrow OTC Company, Mississauga, Ontario l5N 2B8, UPC: 7 71058 10160 4; v) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00066 6; w) Smart sense, Distributed by: Kmart Corgoration, Hoffman Estates, IL 60179, UPC: 7 20007 78036 0; x) sunmark, Cistributed By McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 10939 16733 0, NDC: 49348-037-29; y) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355; UPC: 6 69635 24061 0; z) TopCare, Distributed By Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03639 0; aa) Western Family Foods, Distributed by: Western Family Foods, Inc., P.O. Box 4059, Portland, OR 97208, UPC:0 15400 03420 3;bb) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00614 3.

751,440 Bottles, in FDA’s words.

Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

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.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Barcodes and drug codes

  • NDC 24385-075-05
  • NDC 48879-009-07
  • NDC 62011-0102-1
  • NDC 49348-037-29
  • UPC 761706165003
  • UPC 041163251106
  • UPC 060383736132
  • UPC 032251004599
  • UPC 087701149757
  • UPC 180410000156
  • UPC 041220947317
  • UPC 052569134726
  • UPC 725439933803
  • UPC 075450296044
  • UPC 011110385970
  • UPC 057800196167
  • UPC 041310620427
  • UPC 041250829164
  • UPC 070253966842
  • UPC 041415010765
  • UPC 321130700609
  • UPC 771058101604
  • UPC 015127000666
  • UPC 720007780360
  • UPC 010939167330
  • UPC 669635240610
  • UPC 036800036390
  • UPC 015400034203
  • UPC 690689006143
Source:

As FDA’s description and codes give them; the UPCs written as digits only.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

U.S. Nationwide and Canada (Ontario).

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Dec 4, 2014.
  • FDA classified it on Dec 23, 2014.
  • FDA’s Enforcement Report published it on Dec 31, 2014.
  • FDA terminated it on Oct 26, 2015.
Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • K C Pharmaceuticals Inc, of Pomona, CA.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Drug recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 8, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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