CLASS II Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Sato Clear (naphazoline hydrochloride) Redness Reliever Eye Drops recalled
Sato Pharmaceutical is recalling Sato Clear (naphazoline hydrochloride) Redness Reliever Eye Drops, distributed in Hawaii. The recall was initiated on 16 Feb 2017 and the FDA has classified it as Class II.
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-0855-2017
- FDA event ID
- 77161
- Recalling firm
- Sato Pharmaceutical, Torrance, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2017
- FDA classified
- 23 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 16 Feb 2017 | Recall initiated by company | |
| 23 May 2017 | Classified by FDA | +96 days |
| 31 May 2017 | 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
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Where it was distributed
US: Hawaii, Guam, Saipan, SPI
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Which lots are affected?
Lot #: WXWZ, Exp. March 2019; WXTS, Exp. October 2019
Where was it sold?
US: Hawaii, Guam, Saipan, SPI
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
2 other products · FDA event 77161This product is part of a recall event; the main page for the event is Optic Splash (naphazoline hydrochloride) Eye Drops recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Optic Splash (naphazoline hydrochloride) Eye Drops recalled | Sato Pharmaceutical | Sterility | HI | |
| CLASS II | Dorama-neo (naphazoline hydrochloride) Eye wash recalled | Sato Pharmaceutical | Sterility | HI |
More recalls from Sato Pharmaceutical
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|---|---|---|---|---|---|
| Food | CLASS III | Yunker(branded) Energy & Health Herbal Supplement with Vitamins recalledYunker | Sato Pharmaceutical | Other | Nationwide |
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| Drug | CLASS III | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Wal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolving | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |