The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0444-2020·Announced 2019-11-27

Altaire Recalls OCuSOFT Tetravisc Forte Due to Sterility Concerns

Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Forte eye drops because the company cannot guarantee the product is 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 serious injury or infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 103,856 units of OCuSOFT Tetravisc Forte Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL vials. The recall was initiated because the company lacks assurance that the product is sterile. The affected product is prescription-only and was distributed nationwide in the United States.

The recall covers specific lots with expiration dates ranging from July 2019 to October 2020. The affected lot numbers are 17198, 17199, 17233, 17337, 17338, and 18248. The product was manufactured by Altaire Pharmaceuticals, Inc., in Aquebogue, NY, for OCuSOFT, Inc., in Rosenberg, TX.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
103,856

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 (10)

  • Lot #: 17198
  • Exp 7/19
  • 17199
  • 17233
  • Exp 8/19
  • 17337
  • Exp 11/19
  • 17338
  • 18248
  • Exp 10/20

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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