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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly when involving significant risks such as sterility failures in medical products.
Plain-English summary
Sato Pharmaceutical Inc. is recalling 10,130 bottles of Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles. The product is identified by Lot # XXWC and has an expiration date of August 2018. The recall is being conducted because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas, resulting in a lack of assurance of sterility.
The affected product was distributed in the United States, specifically in Hawaii, Guam, Saipan, and the Northern Mariana Islands (SPI). The product was manufactured by SATO Pharmaceuticals CO., LTD. in Tokyo, Japan.
Consumers who have this product should stop using it and contact Sato Pharmaceutical Inc. for further instructions or a refund. The FDA classifies this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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.
- Manufacturer
- Sato Pharmaceutical Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 10,130
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: XXWC
- Exp. August 2018
Distribution
Part of a larger recall action
This product is one of 3 recalled by Sato Pharmaceutical Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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