Reported Dec 31, 2014 · Terminated
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled
K C Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: K C Pharmaceuticals Inc · 3201 Producer Way · Pomona, CA · 91768-3916
Is this the product you have?
Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled
26 of 26 products
| Model / number | Product as published |
|---|---|
| — | Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3 |
| — | CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3 |
| — | Equaline, DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344, UPC: 0 41163 25110 6 |
| — | 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 |
| — | FAMILY wellness, Distributed by: Family Dollar Services, Inc., 10401 Monroe Rd., Matthews, NC 28105, UPC: 0 32251 00459 9 |
| — | Good Neighbor Pharmacy, Distributed By: AmerisourceBergen 1300 Moris Drive, Chesterbrook, PA 19087, UPC: 0 87701 14975 7, NDC: 24385-075-05 |
| — | GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00015 6, NDC: 48879-009-07 |
| — | H-E-B, Made with Pride and Care for H-E-B, San Antonio, TX 78204, UPC: 0 41220 94731 7 |
| — | Health Mart PHARMACY, Distributed by McKesson One Post STreet, San Francisco, CA 94104, UPC: 0 52569 13472 6, NDC: 62011-0102-1 |
| — | healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93380 3 |
| — | HyVee, Distributed by HY-VEE, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29604 4 |
| — | Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38597 0 |
057800-19616-7 | life BRAND, Imported for SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8 |
| — | life BRAND, Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 0 57800 19616 7 |
| — | LiveBetter, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62042 7 |
| — | meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82916 4 |
| — | Our Family, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN, 55435, UPC: 0 70253 96684 2 |
| — | Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01076 5 |
| — | Redness Relief, Distributed by: Safeway Inc., P.O. BOX 99, PLEASANTON, CA 94566-0009, UPC: 3 21130 70060 9 |
| — | Rexall, Manufactured For: Rexall Brads Corp., Mississauga, Ontario, L4Z 1R9., Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10160 4 |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 3A001, Expiry: 01/16 2 Lot #: 3A002, Expiry: 01/16 3 Lot #: 3B004, Expiry: 02/16 4 Lot #: 3B003, Expiry: 02/16 5 Lot #: 3C005, Expiry: 03/16 6 Lot #: 3C006, Expiry: 03/16 7 Lot #: 3D007, Expiry: 04/16 8 Lot #: 3D008, Expiry: 04/16. - Amount recalled
- 751,440 Bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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