The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0416-2020·Announced 2019-11-27

Altaire Recalls Altachlore Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling 46,345 units of Altachlore Sodium Chloride Ophthalmic Ointment nationwide due to a lack of assurance of sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile ophthalmic product with a lack of assurance of sterility, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 46,345 units of ActivEyes Altachlore Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%. The product is identified by NDC 59390-184-50 and was distributed nationwide in the United States.

The recall was initiated because of a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any specific illnesses or injuries associated with the product.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT (SODIUM CHLORIDE)
Brand
ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
46,345

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)

  • SAP 1/20 3/16/2018 SFI 6/20 8/16/2018 SLA 12/20 1/4/2019 TBM 2/21

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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