The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0436-2016·Announced 2015-12-09

Western Drug Recalls Magnesium Sulfate Injection Due to Sterility Concerns

Western Drug is recalling Magnesium Sulfate 50% Injection because the company cannot ensure the product is sterile. The recall covers four containers 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 source identifies the agency classification as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the snippet, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious harm (sepsis/infection), aligning with the Severe criteria for Class II recalls with potential for significant injury.

Plain-English summary

Western Drug Inc. is recalling four containers of Magnesium Sulfate 50% Injection. The recall was initiated because the company lacks assurance that the product is sterile. The affected product is a prescription medication manufactured by Western Drug Inc. in Springerville, Arizona.

The recall covers all lots of the product. The four containers were distributed nationwide to locations in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.

Healthcare providers and consumers should stop using the recalled product and contact Western Drug Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable
Hazard
Affected units
4

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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