The Recall Desk
SevereFDA (Drugs)·D-0482-2020·Announced 2019-11-27

Altaire Recalls OCuSOFT retaine NaCl Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling OCuSOFT retaine NaCl Ophthalmic Ointment because the product lacks assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 the hazard 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 OCuSOFT retaine NaCl Ophthalmic Ointment, 3.5g, SKU # 777-3-77. The recall was initiated due to a lack of assurance of sterility in the product.

The affected product was distributed nationwide in the United States. The specific lot numbers involved are 18008, 1/20, 19105, and 4/22.

Consumers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77

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 (1)

  • Lot #: 18008 1/20 19105 4/22

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 →