The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0458-2020·Announced 2019-11-27

Altaire Pharmaceuticals Recalls Accutome Rx Accu-WASH Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Accutome Rx Accu-WASH eye drops because the company cannot guarantee the product is 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, which corresponds to a Severe rating under the rubric for significant injury risks or hospitalization reports, though no specific injuries are mentioned in the source text.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 90,072 units of Accutome Rx Accu-WASH, 4 FL OZ (118 mL), NDC 63448-411-04. The recall was initiated because the company lacks assurance of the product's sterility.

The affected product was distributed nationwide in the United States. The specific lot code for the recalled units is 18095 4/20.

Consumers who have this product should stop using it 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
Hazard
Affected units
90,072

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 (1)

  • 18095 4/20

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.

See all 134 products in this recall →

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