The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0372-2020·Announced 2019-11-27

Equate Support Harmony Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling Equate Support Harmony Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 17,613 units 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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for an ophthalmic product represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious consequences.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), distributed by Walmart Stores, Inc. The recall is being conducted due to a lack of assurance of sterility. The affected product is identified by NDC 49035-145-10.

The recall involves 17,613 units distributed nationwide in the U.S.A. The specific lots affected are 17290 (Exp 09/19), 19011 (Exp 01/21), 18052 (Exp 02/20), 18266 (Exp 10/20), 18178 (Exp 07/20), and 17385 (Exp 12/19). Note that Support Harmony packaging was discontinued in January 2018.

Consumers should stop using the recalled product and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
17,613

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 (12)

  • Lot #: 17290
  • Exp 09/19
  • 19011
  • Exp 01/21
  • 18052
  • Exp 02/20
  • 18266
  • Exp 10/20
  • 18178
  • Exp07/20
  • 17385
  • Exp 12/19

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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