The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0477-2020·Announced 2019-11-27

CVS Health Multi-Action Relief Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Multi-Action Relief 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves sterility assurance which poses a risk of infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is voluntarily recalling CVS Health Multi-Action Relief Drops (Item #694954, 15 mL) distributed by CVS Pharmacy, Inc. The recall was initiated because the product lacks assurance of sterility.

The affected product is distributed nationwide in the United States. Specific lots subject to the recall include those with expiration dates ranging from January 2020 to April 2022, including lot numbers 16267, 18096, 18301, 17371, 17158, 17025, 17015, and 19103.

Consumers who have purchased this product should stop using it immediately and return it to the pharmacy where it was purchased for a refund. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic / Eye Drops
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 (16)

  • Lot #: 16267
  • Exp 10/19
  • 18096
  • Exp 04/21
  • 18301
  • Exp 12/21
  • Exp 4/21
  • 17371
  • Exp 12/20
  • 17158
  • Exp 6/20
  • 17025
  • Exp 1/20
  • 17015
  • 19103
  • Exp 04/22

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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Same manufacturer · Altaire Pharmaceuticals, Inc.

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