The Recall Desk
LowFDA (Drugs)·D-1084-2015·Announced 2015-05-27

Oasis Medical Recalls ImproVue Ophthalmic Lubricant Drops for pH Failure

Oasis Medical is recalling specific lots of ImproVue Ophthalmic Lubricant Drops because they failed to meet pH specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Oasis Medical, Inc. is recalling 9,731 cartons of ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose). The affected product is a single-use syringe containing 0.07 fl oz (2mL) of solution, manufactured for OCULUS SURGICAL in Port St. Lucie, FL. The recall covers specific lots with expiration dates of 02/16 and 04/16.

The recall was initiated because the product failed to meet pH specifications. This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
Affected units
9,731

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 (4)

  • Lot# V0814B
  • Exp 02/16
  • V1014H
  • Exp 04/16

Distribution

Distributed in 1 state: