The Recall Desk
SevereFDA (Drugs)·D-0459-2020·Announced 2019-11-27

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.

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, 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
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.

See all 134 products in this recall →