The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0386-2020·Announced 2019-11-27

CVS 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile ophthalmic products.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143). The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is distributed by CVS Pharmacy Inc. and was distributed nationwide in the U.S.A. The recall involves 159,864 units. Specific lot numbers affected include 19087 3/21, 17289 9/19, 19087 03/21, and 18122 5/20.

Consumers should check their inventory for the specific lot numbers listed above. If they have the affected product, they should stop using it and contact CVS Pharmacy Inc. or Altaire Pharmaceuticals, Inc. for further instructions.

The recalled product

Product
CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
159,864

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 3/21 17289 9/19 19087 03/21 18122 5/20

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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