The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0394-2016·Announced 2015-12-09

Western Drug Recalls Prostin Injection Due to Sterility Concerns

Western Drug is recalling Prostin Injection due to a lack of assurance of sterility. The recall covers 16 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are categorized as Severe.

Plain-English summary

Western Drug Inc. is recalling 16 containers of Prostin Injection (10 mcg/mL, 25 mcg/mL, and 50 mcg/mL) due to a lack of assurance of sterility. The affected product is a prescription medication manufactured by Western Drug Inc. in Springerville, Arizona.

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

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable Medication
Hazard
Affected units
16

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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