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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an ophthalmic product.
Plain-English summary
Sato Pharmaceutical Inc. is recalling Sato Clear (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles. The recall involves 4,790 bottles with lot numbers WXWZ (expiring March 2019) and WXTS (expiring October 2019). The product was distributed in Hawaii, Guam, Saipan, and SPI.
The recall was initiated due to a lack of assurance of sterility. The firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. This classification is designated as FDA Class II.
Consumers with these products should stop using them and contact Sato Pharmaceutical Inc. for further instructions or a refund.
The recalled product
- 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
- Manufacturer
- Sato Pharmaceutical Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 4,790
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 (4)
- Lot #: WXWZ
- Exp. March 2019
- WXTS
- Exp. October 2019
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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