CLASS III Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Eye Drops Advanced Relief (Dextran recalled by K C Pharmaceuticals
K C Pharmaceuticals is recalling Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, distributed nationwide in the US. The recall was initiated on 4 Dec 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0323-2015
- FDA event ID
- 69945
- Recalling firm
- K C Pharmaceuticals, Pomona, CA
- Manufacturer
- Strategic Sourcing Services LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Dec 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 4 Dec 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +19 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide and Canada (Ontario).
Stores named: Walmart, Kroger, Publix, H-E-B, Albertsons, Meijer, Hy-Vee
Questions about this recall
Why was it 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 lots are affected?
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.
Where was it sold?
U.S. Nationwide and Canada (Ontario).
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 69945This product is part of a recall event; the main page for the event is Eye Drops A.C. (Tetrahydrozoline HCl recalled by K C Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Eye Drops A.C. (Tetrahydrozoline HCl recalled by K C Pharmaceuticals | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS III | Eye Drops (Tetrahydrozoline HCl 0.05%), Over the Counter recalledSunmark Eye Drops Original Formula | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS III | Eye Drops Industrial Strength (Polyethylene glycol recalled | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from K C Pharmaceuticals
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Eye Drops Soothing Tears recalled by K.C. Pharmaceuticals | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | EYE Drops Advanced Relief, (dextran recalled by K.C. PharmaceuticalsQuality Choice Moisturizing Relief Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile Eye Drops Redness Lubricant (glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Dry Eye Relief Eye Drops, (glycerin recalled by K.C. PharmaceuticalsArtificial Tears | K.C. Pharmaceuticals | Sterility | Nationwide |