The Recall Desk
ModerateFDA (Drugs)·D-1817-2015·Announced 2015-09-30

Allergan Recalls Refresh Lacri-Lube Eye Ointment Due to Particulate Matter

Allergan is recalling Refresh Lacri-Lube eye ointment because unscrewing the cap may introduce small black particles into the product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential particulate contamination from the packaging cap, which is a moderate risk without reported serious injuries.

Plain-English summary

Allergan Sales, LLC is recalling Refresh Lacri-Lube (Mineral Oil, Petrolatum) Lubricant Eye Ointment. The recall involves 320,713 tubes distributed nationwide, in Puerto Rico, and in Barbados. The product is available in 0.12 oz and 0.25 oz tubes.

The recall was initiated due to customer complaints regarding the presence of small black particles. These particles are identified as fragments of the ointment tube cap that can be generated when unscrewing the cap from the aluminum tube. This action may potentially introduce the particles into the product.

Consumers with this product should stop using it and contact Allergan Sales, LLC for further instructions or a refund. The affected lots include specific expiration dates ranging from April 2017 to November 2017.

The recalled product

Product
REFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM)
Brand
REFRESH LACRI-LUBE
Manufacturer
Allergan Sales, LLC
Category
Drug — Ophthalmic Ointment
Hazard
Affected units
320,713

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 #: a) 84746
  • Exp 04/17
  • 84987
  • 85087
  • Exp 05/17
  • 85359
  • Exp 06/17
  • 85721
  • Exp 07/17
  • 86045
  • Exp 08/17
  • 86406
  • Exp 09/17
  • 86594
  • Exp 10/17
  • 87021
  • Exp 11/17
  • and b) 86470
  • 86829
  • 87105

UPCs (2)

  • 300230312042
  • 300230312073

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Allergan Sales, LLC 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 4 products in this recall →

Related recalls

Same manufacturer · Allergan Sales, LLC

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Same hazard · particulate matter

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