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.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility failure in a sterile eye wash product.
Plain-English summary
Sato Pharmaceutical Inc. is recalling 14,325 bottles of DORAMA-NEO (naphazoline hydrochloride) Eye wash. The product is packaged in 0.5 FL OZ (15mL) bottles and carries NDC 49873-020-01. The specific lot affected is WXTZ, with an expiration date of September 2019.
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 defect raises the potential for microbial contamination of the sterile eye wash product.
The affected product was distributed in the United States, specifically in Hawaii, Guam, Saipan, and the Northern Mariana Islands (SPI). Consumers who have this product should stop using it and contact Sato Pharmaceutical Inc. for instructions on return or disposal.
The recalled product
- 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
- Manufacturer
- Sato Pharmaceutical Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 14,325
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 #: WXTZ
- Exp. Sep 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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