The Recall Desk
SevereFDA (Drugs)·D-0406-2016·Announced 2015-12-09

Western Drug Recalls Gent Nasal Spray Due to Sterility Concerns

Western Drug is recalling Gent 80 mg/Liter Nasal spray because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

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 the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in a nasal product) fall under the 'Severe' category (Score 4).

Plain-English summary

Western Drug Inc. is recalling Gent 80 mg/Liter Nasal, a prescription medication, due to a lack of assurance of sterility. The recall includes all lots of the product. The medication was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.

The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is the potential presence of non-sterile conditions in the nasal spray, which could pose a risk to patients using the product.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or alternative treatments. The recall is being conducted to ensure patient safety and to prevent potential adverse health effects associated with non-sterile medical products.

The recalled product

Product
Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Nasal Spray
Hazard
Affected units
1

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)

  • all lots

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 91 recalled by Western Drug 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 91 products in this recall →

Related recalls

Same manufacturer · Western Drug

See all →

Same hazard · lack of sterility

See all →