The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0437-2016·Announced 2015-12-09

Western Drug Recalls Marcaine Injection Due to Sterility Concerns

Western Drug Inc. is recalling 5 containers of Marcaine 0.24%/Ethanol 4% Injection because the product lacks assurance of sterility.

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/property-damage reports or structural defects are Severe; while no injuries are reported here, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of harm (infection) that aligns with the Severe tier for high-risk products where injury has not yet been reported but the hazard is serious.

Plain-English summary

Western Drug Inc. is recalling 5 containers of Marcaine 0.24%/Ethanol 4% Injection. The recall is being conducted because the product lacks assurance of sterility. The affected product is a prescription medication manufactured by Western Drug Inc. located in Springerville, Arizona.

The recall covers all lots of the product. Distribution was nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable Anesthetic
Hazard
Affected units
5

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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