The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0422-2016·Announced 2015-12-09

Western Drug Recalls Calcium EDTA Injection Due to Sterility Concerns

Western Drug is recalling Calcium EDTA 300mg/mL Injection because the product lacks assurance of sterility. The recall affects two 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for significant harm.

Plain-English summary

Western Drug Inc. is recalling two containers of Calcium EDTA 300mg/mL Injection. The recall was initiated because the product lacks assurance of sterility. This is a prescription medication manufactured by Western Drug Inc. in Springerville, Arizona.

The affected product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall covers all lots of the product.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injection
Hazard
Affected units
2

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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