The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-087-2013·Announced 2012-12-12

Genentech Recalls Nutropin AQ NuSpin 20 Due to Defective Delivery System

Genentech is recalling 10,306 syringes of Nutropin AQ NuSpin 20 because the dose knob may spin slowly, causing delayed injection delivery.

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 2/5 (Moderate).

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 issue involves a mechanical defect in the delivery system that affects the speed of injection rather than the safety or purity of the drug itself, fitting the criteria for a moderate risk.

Plain-English summary

Genentech Inc is recalling 10,306 syringes of Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection) 20 mg/2mL. The affected product is identified by Lot #936674 with an expiration date of 09/30/13. The recall is being conducted nationwide.

The recall was initiated after Genentech received complaints regarding the Nutropin AQ NuSpin 10 and 20 delivery systems. Users reported that the dose knob spun slowly and that the injection process took longer than usual, indicating slow dose delivery.

Consumers who have this specific lot of Nutropin AQ NuSpin 20 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 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Manufacturer
Genentech Inc
Category
Drug — Biologic / Injection
Hazard
Affected units
10,306

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# 936674 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 →

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