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FDAFebruary 16, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

sato pharmaceuticalsato

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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