The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0476-2020·Announced 2019-11-27

CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues

Altaire Pharmaceuticals is recalling CVS Health Preservative Free 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no injuries are explicitly reported, the lack of sterility assurance in a drug product is a significant safety hazard that aligns with the Severe criteria for Class II recalls where the risk is not merely theoretical or cosmetic.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief (Item#: 634634). The product is distributed by CVS Pharmacy, Inc. and consists of 0.6 mL x 30 units.

The recall was initiated because of a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or report any specific illnesses or injuries associated with the product.

Approximately 114,504 units were distributed nationwide in the U.S.A. Consumers should stop using the product and contact CVS Pharmacy or Altaire Pharmaceuticals for further instructions or a refund.

The recalled product

Product
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
114,504

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)

  • SEI 5/20 TAK 01/21

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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