Agency classClass IIOur severity:Severe FDA (Drugs)·D-371-2013·Announced 2013-05-22

Green Valley Drugs Recalls Hyaluronidase Injection Due to Sterility Concerns

Green Valley Drugs is recalling 996 vials of Hyaluronidase Injection because the pharmacy could not ensure the products were sterile.

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, and the hazard involves a lack of sterility assurance for injectable products, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 996 vials of Hyaluronidase Injection, available in various strengths and presentations including Hyaluronidase 150u/mL, Hyaluronidase 150u/ml 1 mL PF, and Hyaluronidase 150u/mL PF 1ml SDV. The recall covers all sterile products compounded, repackaged, and distributed by the pharmacy.

The recall was initiated due to a lack of assurance of sterility and concerns regarding the pharmacy's quality control processes. The affected products were distributed nationwide.

Consumers who have purchased these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer: FVS Holdings, Inc. dba. Green Valley Drugs
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 996

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 (6)

Lot #: a) Hyaluronidaise 150u/mL: 20130205-G
Exp 5/5/2013
b) Hyaluronidase 150u/mL 1 mL PF: 20130321-A
Exp 6/21/2013
c) Hyaluronidase 150u/mL PF 1ml SDV: 20130313-E
Exp 6/13/2013. .

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs 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 78 products in this recall →

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

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