CLASS III Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Eye Drops A.C. (Tetrahydrozoline HCl recalled by K C Pharmaceuticals
K C Pharmaceuticals is recalling Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), Over the Counter, 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-0321-2015
- FDA event ID
- 69945
- Recalling firm
- K C Pharmaceuticals, Pomona, CA
- 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
- Eye Drops
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 A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47010 6; c) EQUALINE, Distributed by Supervalu Inc., Eden Prairie, MN, UPC: 0 41163 25114 4; d) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00018 7, NDC: 48879-010-07; e) H-E-B, Made for: H-E-B, San Antonio, TX 78204, UPC: 0 41220 86936 7; f) healthy accents, Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93382 7; g) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29777 5; h) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38599 4; i) life, Imported for/Importe pour: SHOPPERS DRUG MART PHARMAPRIX., Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 19617 4; j) LiveBetter, Distributed By Onpoint. Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62041 0; k) meijer, Dist. by Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82918 8; l) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01176 2; m) QUALITY CHOICE, Distributed by Quality Choice, Novi, MI 48376, UPC: 6 35515 99505 5; n) REDNESS RELIEF ASTRINGENT, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC: 0 50428 79686 3; o)Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; p) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; q) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00363 6; r) Smart sense, Distributed by: Kmart Corporation, Hoffman Estates, IL 60179, UPC: 7 20007 96092 2; s) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03640 6; t)WESTERN FAMILY, Distributed by Western Family Foods, Inc., P.O. Box 4057 Portland, OR 97208, UPC: 0 15400 04552 0.
Where it was distributed
U.S. Nationwide and Canada (Ontario).
Stores named: Kroger, Publix, H-E-B, Albertsons, Meijer, CVS, 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 #: 3B251, Expiry: 02/16; Lot #: 3B250, Expiry: 02/16; Lot #: 3B251, Expiry: 02/16; Lot #: 3C252, Expiry: 03/16; Lot #: 3C253, 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 69945| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Eye Drops Advanced Relief (Dextran recalled by K C PharmaceuticalsSunmark Eye Drops Advanced Moisturizer/lubricant | 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 |