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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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