The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0456-2020·Announced 2019-11-27

CVS Health Lubricating Gel Drops Recalled for Sterility Assurance Issues

Altaire Pharmaceuticals is recalling CVS Health Lubricating Gel Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in a medical product) are categorized as Severe (Score 4), particularly when the agency classification mandates a minimum of 4.

Plain-English summary

Altaire Pharmaceuticals, Inc. is voluntarily recalling CVS Health Lubricating Gel Drops for Anytime Use (Item#: 563420, 10 mL). The recall was initiated because the product lacks assurance of sterility. The product was distributed nationwide in the United States by CVS Pharmacy, Inc.

The affected product is identified by the following lot codes and expiration dates: 17238 08/19, 18094 4/20, and 19058 02/21. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased this product should stop using it immediately and return it to the pharmacy where it was purchased for a refund. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Medical Device — Lubricants
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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