The Recall Desk
SevereFDA (Drugs)·D-0382-2020·Announced 2019-11-27

CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no injuries are reported, the lack of sterility assurance in a medical product warrants a higher severity rating than a standard Class II labeling error.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution (Item #495334, 0.6 mL x 60 count). The recall is being conducted because of a lack of assurance of sterility in the product. The affected units were distributed nationwide by CVS Pharmacy Inc.

The recall involves 45,864 units across multiple lots with expiration dates ranging from July 2019 to July 2020. Specific lot numbers include RGF, RHN, RIH, RJP, RKN, SDC, SFC, SFJ, and SGI. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased these eye drops should stop using them immediately. They should return the product to the pharmacy where it was purchased for a refund or contact CVS Pharmacy Inc. for further instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
45,864

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 (16)

  • Lot #: RGF
  • Exp 07/19
  • RHN
  • Exp 08/19
  • RIH
  • Exp 09/19
  • RJP
  • Exp 10/19
  • RKN
  • Exp 11/19
  • SDC Exp 04/20
  • SFC
  • Exp 06/20
  • SFJ
  • SGI
  • Exp 07/20

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 →

Related recalls

Same manufacturer · Altaire Pharmaceuticals, Inc.

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Same hazard · sterility

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