The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0476-2016·Announced 2015-12-09

Western Drug Recalls Lipodissolve Injection Due to Sterility Concerns

Western Drug is recalling Lipodissolve 100/50mg Injection Solution because the company cannot assure 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the snippet, the lack of sterility assurance for an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious adverse health consequences.

Plain-English summary

Western Drug Inc. is recalling Lipodissolve 100/50mg Injection Solution, a prescription medication. The recall was initiated because the company lacks assurance of the product's sterility.

The affected product is distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. All lots of the product are included in this recall.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injection
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 →

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