Severity
Low
FDA Drug recall · Reported December 31, 2014
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
K C Pharmaceuticals Inc recalled Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labe… - a low-severity action.
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labe… was recalled by K C Pharmaceuticals Inc in December 31, 2014. Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP complian…. Check the official notice for the remedy. Verify recall #D-0320-2015 with the FDA Drug before acting.
The recall
K C Pharmaceuticals Inc issued this low-severity FDA Drug recall-CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP complian….
Sourced from official FDA Drug enforcement records. Verify recall #D-0320-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 751,440 Bottles.
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.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
751,440 Bottles
Related Recalls
6
5 from same agency
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.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
| 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 |
| Firm location | Pomona, CA |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 31, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.