The Recall Desk
SevereFDA (Drugs)·D-0436-2020·Announced 2019-11-27

Altaire Recalls Ofloxacin Ophthalmic Solution Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Ofloxacin Ophthalmic Solution, 0.3%, due to a lack of assurance of sterility. The recall affects 102,939 units distributed nationwide.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in ophthalmic products) are mapped to a score of 4 (Severe), as they are not Class I but involve significant risk.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, NDC 59390-140-05. The recall is being conducted due to a lack of assurance of sterility. The affected product is a prescription-only ophthalmic solution.

The recall involves 102,939 units distributed nationwide in the United States. The source text lists the following lot codes and expiration dates: 17244 8/19, 18057 3/20, and 518307 12/20.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
OFLOXACIN OPHTHALMIC (OFLOXACIN)
Brand
OFLOXACIN OPHTHALMIC
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
102,939

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)

  • 17244 8/19 18057 3/20 518307 12/20

UPCs (1)

  • 593901400517

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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Same hazard · sterility

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