Food, drugs, devices › Sato Pharmaceutical Inc.
Drug recall: Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceu
FDA enforcement event 77161 is a drug recall by Sato Pharmaceutical Inc. of Torrance, CA, initiated 16 Feb 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 13 Mar 2018. Initiation: voluntary: firm initiated. Sato Pharmaceutical Inc. has 4 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sato Pharmaceutical Inc., Torrance, CA.
Reason for recall
"Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas."
Distribution
"US: Hawaii, Guam, Saipan, SPI"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0854-2017 | Optic Splash (naphazoline hydrochloride) 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 49873-501-01. | 10,130 bottles | Class II | Terminated | 31 May 2017 |
| D-0855-2017 | 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 | 4,790 bottles | Class II | Terminated | 31 May 2017 |
| D-0856-2017 | 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 | 14,325 bottles | Class II | Terminated | 31 May 2017 |
Context
Other enforcement events for Sato Pharmaceutical Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Mar 2026 | Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml con | Food | Class III | 1 |
| 1 Oct 2019 | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. West | Drug | Class III | 4 |
| 1 Oct 2019 | Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by | Drug | Class III | 1 |
All 4 events for Sato Pharmaceutical Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: Hawaii, Guam, Saipan, SPI"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Mar 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.