CLASS II Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Dorama-neo (naphazoline hydrochloride) Eye wash recalled
Sato Pharmaceutical is recalling Dorama-neo (naphazoline hydrochloride) Eye wash, 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-0856-2017
- 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
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
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
Where it was distributed
US: Hawaii, Guam, Saipan, SPI
Stores named: Walmart
Questions about this recall
Is Dorama-neo (naphazoline hydrochloride) Eye wash recalled?
Yes. Sato Pharmaceutical recalled Dorama-neo (naphazoline hydrochloride) Eye wash on 16 Feb 2017. The recall is Class II and its status is Terminated. Recall number D-0856-2017.
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 #: WXTZ, Exp. Sep 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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