FDA Drug recall D-0855-2017
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceutica…
- FDA Drug
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceutica… by Sato Pharmaceutical, citing lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0855-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-16 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sato Pharmaceutical |
| Distribution | HI |
Product
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
Reason
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Identifiers
| code_info | Lot #: WXWZ, Exp. March 2019; WXTS, Exp. October 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0855-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.