The Recall Desk
SevereFDA (Drugs)·D-0485-2020·Announced 2019-11-27

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.

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 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
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 (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.

See all 134 products in this recall →

Related recalls

Same manufacturer · Altaire Pharmaceuticals, Inc.

See all →

Same hazard · sterility

See all →