Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Sterile EYE DROPS REDNESS LUBRICANT (Glycerin, Naphazoline Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4
Affected NDCs
11822-6453-04
46122-0606-05
70000-0010-01
70677-1161-01
Compare with the code on your package — it is the most precise check available.
Drug: Naphazoline Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Leader Eye Drops Redness Relief Glycerin, Naphazoline hydrochloride NDC 70000-0010 |
GLYCERIN .25 g/100mL; NAPHAZOLINE HYDROCHLORIDE .012 g/100mL | Solution/ Drops Ophthalmic |
Cardinal Health | OTC |
| Foster and Thrive Redness Relief Eye Drops Glycerin, Naphazoline HCl NDC 70677-1161 |
NAPHAZOLINE HYDROCHLORIDE .012 g/100mL; GLYCERIN .25 g/100mL | Solution/ Drops Ophthalmic |
Strategic Sourcing Services LLC | OTC |
- Recalling firm
- K.C. Pharmaceuticals, Inc
- NDC code
- 46122-606-05
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0414-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Naphazoline recalls
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Class II · Moderate risk
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