Agency classClass IIOur severity:Severe FDA (Drugs)·D-391-2013·Announced 2013-05-22

Green Valley Drugs Recalls Methylprednisolone Injection Due to Sterility Concerns

Green Valley Drugs is recalling 720 syringes of Methylprednisolone, Lidocaine, and Sodium Chloride 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 involves a lack of sterility assurance for injectable drugs, which poses a significant risk of serious injury or death from infection.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling 720 syringes of Methylprednisolone, Lidocaine, and Sodium Chloride Injection. The recall covers all strengths and presentations, including Methylpred-Lido-Nacl-1-5-6-12 syringes and Methylpred80mg/lido1%/Sodium Chloride0.9% syringes. The products were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The FDA identified concerns associated with the quality control processes used to compound, repackage, and distribute these sterile products by the compounding pharmacy.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer: FVS Holdings, Inc. dba. Green Valley Drugs
Category: Drug — Injectable Sterile Compounded Drug
Hazard: sterility-failure
infection-risk
Affected units: 720

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 (9)

Lot #: a) Methylpred-Lido-Nacl-1-5-6-12 syringe: 20120226-GV3
Exp 5/26/2013
13012370GV3
Exp 4/23/2013
13012480
Exp 4/24/2013
13011550
Exp 4/15/2013
b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr: 13012370-GV3

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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Same hazard · sterility failure