The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0428-2016·Announced 2015-12-09

Western Drug Recalls HCG Injection Due to Sterility Assurance Concerns

Western Drug is recalling HCG 10,000U/10mL Injection because the product lacks assurance of sterility. 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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug is classified as Severe (Score 4), particularly given the potential for serious injury from non-sterile injections.

Plain-English summary

Western Drug Inc. is recalling HCG 10,000U/10mL Injection, a prescription medication. The recall is being conducted because the product lacks assurance of sterility. This issue affects all lots of the product.

The recalled product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall involves 8 containers of the medication.

Consumers and healthcare providers should stop using the recalled HCG 10,000U/10mL Injection and contact their healthcare provider for further instructions or to obtain a replacement if appropriate.

The recalled product

Product
HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona
Manufacturer
Western Drug
Category
Drug — Injectable
Hazard
Affected units
8

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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