The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0440-2016·Announced 2015-12-09

Western Drug Recalls 18 Containers of Omnitrope Injection Kits

Western Drug is recalling 18 containers of Omnitrope 17.4U/10mL Injection Kits due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable drug) are classified as Severe (Score 4), as they are not Class I (Critical) but involve significant risk.

Plain-English summary

Western Drug Inc. is recalling 18 containers of Omnitrope 17.4U/10mL Injection Kits. The recall was initiated because the product lacks assurance of sterility. This is a prescription medication 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 for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Prescription Injection
Hazard
Affected units
18

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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