The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0401-2020·Announced 2019-11-27

CVS Health Lubricating Gel Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Lubricating Gel Drops due to a lack of assurance of sterility. The product was distributed nationwide.

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 severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL. The recall is being conducted because of a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc. and was available nationwide in the United States.

The affected product codes are 17238 08/19, 18094 4/20, and 19058 02/21. The source text does not specify the total number of units recalled or report any specific illnesses or injuries associated with the product.

Consumers should stop using the product and check their lot numbers against the codes listed above. For more information, consumers should contact the recalling firm or refer to the official FDA recall notice.

The recalled product

Product
CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
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)

  • 17238 08/19 18094 4/20 19058 02/21

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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