The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0454-2020·Announced 2019-11-27

CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues

Altaire Pharmaceuticals is recalling CVS Health Extra Strength Lubricant Gel Drops 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 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 classification is FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance for a medical product warrants a high severity rating consistent with Class II classifications involving potential significant harm.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Extra Strength Lubricant Gel Drops Twin Pack (Item#: 258587, 2 x 15 mL). The recall is being conducted because of a lack of assurance of sterility.

The affected product is distributed by CVS Pharmacy, Inc. in Woonsocket, RI. The recall covers 50,304 units distributed nationwide in the U.S.A. The specific lot numbers involved are 19087 (expiration 03/21), 18122 (expiration 5/20), and 17289 (expiration 9/19).

Consumers should check their inventory for these specific lot numbers and stop using the product if they match the recalled items.

The recalled product

Product
CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Medical Device — Ophthalmic
Hazard
Affected units
50,304

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)

  • Lot #: 19087 03/21 18122 5/20 17289 9/19

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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