PlainRecalls
FDA Drug Verify with FDA Drug → Low Class III Terminated

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

Reported: December 31, 2014 Initiated: December 4, 2014 #D-0320-2015 751,440 Bottles units

K C Pharmaceuticals Inc issued this FDA Drug recall on December 31, 2014. Classified as Low severity (Class III). Approximately 751,440 Bottles units are affected. The recall was issued because: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehous…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Drug action (record #D-0320-2015) was formally reported on December 31, 2014, with the manufacturer initiating the action on December 4, 2014. It is classified under Low severity (Class III), with a current status of Terminated. K C Pharmaceuticals Inc is listed as the recalling firm, operating out of Pomona, CA. Federal records indicate 751,440 Bottles units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. Distribution data in the federal record shows the product reached: U.S. Nationwide and Canada (Ontario).. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Low

Units Affected

751,440 Bottles

Related Recalls

6

0 from same agency

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
K C Pharmaceuticals Inc
Units Affected
751,440 Bottles
Distribution
U.S. Nationwide and Canada (Ontario).
Location
Pomona, CA

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-0320-2015
Date reported December 31, 2014
Date initiated December 4, 2014
Recalling firm K C Pharmaceuticals Inc
Units affected 751,440 Bottles
Distribution U.S. Nationwide and Canada (Ontario).

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

751,440 Bottles units affected — multi-state distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was 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.. Recalled by K C Pharmaceuticals Inc. Units affected: 751,440 Bottles.
Why was this product recalled?
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 31, 2014. Severity: Low. Recall number: D-0320-2015.
Where was the recalled product distributed?
Distribution: U.S. Nationwide and Canada (Ontario)..
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0320-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. Recall severity varies based on the likelihood and degree of potential harm to consumers. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).