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 Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetr… - a low-severity action.
Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetr… 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-0323-2015 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-0323-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0323-2015) 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 427,512 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
427,512 Bottles
Related Recalls
6
5 from same agency
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.
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-0323-2015 |
| Date reported | December 31, 2014 |
| Date initiated | December 4, 2014 |
| Recalling firm | K C Pharmaceuticals Inc |
| Firm location | Pomona, CA |
| Affected scope | 427,512 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.