Altaire Recalls Oftal-Mycin Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Grandall Colirio Oftal-Mycin Redness Relief Eye Drops because the product may lack assurance of sterility.
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 Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, 15mL bottles. The recall is due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # 17008 with an expiration date of 01/20. A total of 73,548 units were distributed nationwide in the United States.
Consumers should stop using the recalled eye drops and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 73,548
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 (2)
- Lot #: 17008
- Exp 01/20
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.
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