The Recall Desk

FDA (Drugs) recall action 77161

Sato Pharmaceutical Inc. recalled 3 products on 2017-05-31

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-05-31
Critical
0
Units
29,245

Why these products were recalled

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Drugs)··2017-05-31

    Sato Clear Eye Drops Recalled for Sterility Assurance Failure

    Sato Pharmaceutical is recalling Sato Clear eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    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
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2017-05-31

    Sato Pharmaceutical Recalls Optic Splash Eye Drops Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 10,130 bottles of Optic Splash eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    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.
    Category
    Distribution
    2 states
  • SevereFDA (Drugs)··2017-05-31

    Sato Pharmaceutical Recalls DORAMA-NEO Eye Wash Due to Sterility Concerns

    Sato Pharmaceutical Inc. is recalling 14,325 bottles of DORAMA-NEO eye wash because the manufacturer failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

    Product
    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
    Category
    Distribution
    2 states