The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-356-2013·Announced 2013-05-22

Green Valley Drugs Recalls Cyclosporine Injection Due to Sterility Concerns

Green Valley Drugs is recalling Cyclosporine Injection products due to a lack of assurance of sterility and quality control concerns.

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 sterile injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Cyclosporine Injection, all strengths and all presentations, including Cyclosporine 2% Aqueous Solution 15 mL. The affected products are prescription-only and were distributed nationwide. The specific lot number is 20130122-F with an expiration date of 4/22/2013.

The recall was initiated because of a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes as the reason for the action.

Consumers and healthcare providers should stop using the affected Cyclosporine Injection products and contact their healthcare provider for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
1

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 (2)

  • Lot #: 20130122-F
  • Exp 4/22/2013

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 →

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