The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0475-2020·Announced 2019-11-27

Altaire Recalls Equate Lubricant Gel Drops Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricant Gel Drops because the product lacks 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 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues for medical products.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL (NDC 49035-882-52). The recall was initiated because the product lacks assurance of sterility.

The affected product was distributed nationwide in the United States. The specific lot codes involved in this recall are 19015 (01/21), 19117 (04/21), 18080 (07/20), and 18111 (05/20).

Consumers should check their inventory for these specific lot codes and stop using the product if it matches the recalled items. No specific instructions for disposal or return are provided in the source text.

The recalled product

Product
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic / Lubricant
Hazard

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)

  • 19015 01/21 19117 04/21 18080 07/20 18111 05/20

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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