Altaire Recalls Diclofenac Sodium Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling 390 units of Diclofenac Sodium Ophthalmic Solution 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
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 risk of harm even without reported injuries.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 390 units of Diclofenac Sodium Ophthalmic Solution, 0.1%, 2.5 mL. The product is a prescription-only ophthalmic solution manufactured by Altaire Pharmaceuticals. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is identified by NDC 59390-149-02 and has a lot code of 17247 with an expiration date of 8/19. The recall covers distribution across the United States nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. Altaire Pharmaceuticals is the recalling firm responsible for this action.
The recalled product
- Product
- DICLOFENAC (DICLOFENAC SODIUM)
- Brand
- DICLOFENAC
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 390
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)
- 17247 8/19
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 →Related recalls
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