Accutome Rx Accu-WASH Recalled Due to Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling Accutome Rx Accu-WASH eye drops because the product may not be sterile.
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, and the hazard involves a lack of sterility assurance for a medical product, which poses a significant risk of infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Accutome Rx Accu-WASH, 4 FL OZ (118 mL), manufactured for Accutome Inc. The recall is being conducted because the product lacks assurance of sterility.
The recall involves 90,072 units distributed nationwide in the U.S.A. Affected lots include codes 16250, 17088, 17307, 17323, 18014, 18228, 18261, and 19119.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 90,072
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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