The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-354-2013·Announced 2013-05-22

Green Valley Drugs Recalls Vitamin D3 Injections Due to Sterility Concerns

Green Valley Drugs is recalling Vitamin D3 injections because the pharmacy could not ensure the products were sterile. The recall covers 18 vials distributed nationwide.

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. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance in injectable products corresponds to a severity score of 4 (Severe).

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 18 vials of Vitamin D3 Injection. The affected products include Cholecalciferol D3 50,000iu 30 mL, Calcitriol D3 10,000iu, and Calcitriol D3 50,000iu. These are prescription-only medications distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to concerns associated with the quality control processes. The specific lot number is 20130130-A, with an expiration date of 4/30/2013.

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
Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, 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
18

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 #: 20130130-A
  • Exp 4/30/2013

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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