Altaire Recalls OCuSOFT Eye Wash Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Eye Wash Sterile Isotonic because the product may not be sterile. Consumers should stop using the product and contact the manufacturer.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an eye product) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), NDC 54799-565-59. The recall was initiated due to a lack of assurance of sterility in the product. The affected units were distributed nationwide in the United States.
The recall involves 296,314 units of the eye wash. The specific lot codes and expiration dates are listed in the structured product information provided by the agency. The product is manufactured by Altaire Pharmaceuticals, Inc. in Aquebogue, NY, for OCuSOFT, INC in Richmond, TX.
Consumers who have this product should stop using it immediately. They should contact Altaire Pharmaceuticals, Inc. for further instructions on how to return or dispose of the product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 296,314
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, 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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