The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0367-2020·Announced 2019-11-27

Altaire Recalls Equate Eye Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Equate Restore PM Nighttime Lubricant Eye Ointment because the product may not be sterile.

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 and involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection and potential serious injury.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g). The recall is being conducted due to a lack of assurance of sterility. The product is distributed by Walmart Stores Inc. and is identified by NDC 49035-191-50.

The recall covers 1,537,130 units distributed nationwide in the U.S.A. Affected lots include SKG, SHK, SHJ, SEC, SCB, SBC, RLB, RBB, RHR, RFK, RAB, TAD, TAQ, TBI, TDB, QHE, QJD, and SGE, with expiration dates ranging from 01/20 to 04/22.

Consumers should stop using the product and return it to the place of purchase for a refund. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1,537,130

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 (20)

  • Lot #: SKG
  • Exp 08/21
  • SHK
  • Exp 08/21
  • SHJ
  • SEC
  • Exp 05/21
  • SCB
  • Exp 03/21
  • SBC
  • Exp 02/21
  • RLB
  • Exp 12/20
  • RBB
  • Exp 02/20
  • RHR
  • Exp 08/20
  • RFK
  • Exp 06/20
  • RAB

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.

See all →

Same hazard · sterility failure

See all →

Similar recalls