Altaire Recalls Grandall Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Grandall Colirio Ojo De Aguila 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL). The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is distributed by Grandall Distributing Co.Inc. in Glendale, CA.
The recall covers 73,548 units distributed nationwide in the U.S.A. The specific lot codes involved are 17131 (expiration 5/20), 18031 (expiration 1/21), and 19065 (expiration 3/22).
Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- 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 (1)
- 17131 5/20 18031 1/21 19065 3/22
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.
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