The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0474-2016·Announced 2015-12-09

Western Drug Recalls Sodium Hydroxide 10% Injection Due to Sterility Concerns

Western Drug is recalling Sodium Hydroxide 10% Injection because the company cannot ensure the product is sterile. The recall covers all 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Western Drug Inc. is voluntarily recalling Sodium Hydroxide 10% Injection. The recall is being conducted because the company lacks assurance that the product is sterile. The affected product is a prescription medication available in 1-container quantities.

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

Healthcare providers and patients should stop using the recalled product and contact Western Drug Inc. for further instructions. Consumers should not use the product if they have questions about its sterility or safety.

The recalled product

Product
Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable Medication
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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