The Recall Desk
ModerateFDA (Drugs)·D-088-2013·Announced 2012-12-12

Genentech Recalls Nutropin AQ NuSpin 10 Due to Defective Delivery System

Genentech is recalling 12,791 syringes of Nutropin AQ NuSpin 10 because the dose knob may spin slowly, causing delayed injection delivery.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in the delivery system (slow dose delivery) rather than a direct chemical or biological contamination risk, fitting the criteria for a moderate severity recall.

Plain-English summary

Genentech Inc is recalling 12,791 syringes of Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection) 10 mg/2mL. The affected product is identified by Lot # 936670 with an expiration date of 09/30/13. The recall is being conducted nationwide.

The recall was initiated after Genentech received complaints regarding the product's delivery system. Users reported that the dose knob spun slowly and the injection took longer than usual to deliver the dose. This issue is described as a miscalibrated and/or defective delivery system.

Consumers and healthcare providers with this specific lot of Nutropin AQ NuSpin 10 should stop using the product and contact Genentech or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Manufacturer
Genentech Inc
Affected units
12,791

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)

  • Lot # 936670 Exp. 09/30/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Genentech Inc 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 2 products in this recall →