The Recall Desk
SevereFDA (Drugs)·D-0429-2016·Announced 2015-12-09

Western Drug Recalls Heparin Injection Due to Sterility Concerns

Western Drug is recalling Heparin 1000 Unit/mL Injection because the product lacks assurance of sterility. The recall covers two containers distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. 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 death from infection.

Plain-English summary

Western Drug Inc. is recalling Heparin 1000 Unit/mL Injection, a prescription medication. The recall was initiated because the product lacks assurance of sterility. The affected product consists of two containers.

The recalled product was 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 or pharmacist for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
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 →