The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0486-2020·Announced 2019-11-27

Altaire Recalls Grandall Oftal-Mycin Ophthalmic Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Grandall Oftal-Mycin Ophthalmic Ointment because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in ophthalmic products which pose a risk of infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Grandall Oftal-Mycin Ophthalmic Ointment, 3.5 g, due to a lack of assurance of sterility. The affected product is distributed nationwide in the United States.

The recall includes the following lot numbers and expiration dates: QJD (Exp 10/19), RFK (Exp 6/20), SCB (Exp 3/21), and TBI (Exp 2/22). The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

Consumers should stop using the recalled ointment and contact their healthcare provider or pharmacist for guidance on next steps. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Ointment
Hazard

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 (8)

  • Lot #: QJD
  • Exp 10/19
  • RFK
  • Exp 6/20
  • SCB
  • Exp 3/21
  • TBI
  • Exp 2/22

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 →

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