openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 3
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.
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Code information
Lot #: XXWC, Exp. August 2018
Distribution pattern
US: Hawaii, Guam, Saipan, SPI
drug · product 2 of 3
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
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Code information
Lot #: WXWZ, Exp. March 2019; WXTS, Exp. October 2019
Distribution pattern
US: Hawaii, Guam, Saipan, SPI
drug · product 3 of 3
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
